Cook Endoscopy
FDA adverse event reports naming Cook Endoscopy as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COOK ENDOSCOPY.
- Total reports
- 5,811
- Deaths
- 20
- Injuries
- 834
- Malfunctions
- 4,949
Reports per year
Source: FDA adverse event reports by year received, 2008–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS1,421
- Ligator, EsophagealMND707
- Dilator, EsophagealKNQ680
- Hemostatic Metal Clip For The Gi TractPKL517
- Hemostatic Device For Endoscopic Gastrointestinal UseQAU472
- Forceps, Biopsy, Non-ElectricFCL464
- Endoscopic Guidewire, Gastroenterology-UrologyOCY257
- Stents, Drains And Dilators For The Biliary DuctsFGE232
- Dislodger, Stone, Basket, Ureteral, MetalFFL183
- Tubes, Gastrointestinal (And Accessories)KNT155
Recent recalls
- 2011-06-28TerminatedDevice Design
Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.
The disposable clip may not deploy after being positioned inside the patient.
- 2011-01-19TerminatedOther
DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
- 2011-01-19TerminatedOther
DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes.
- 2010-10-19TerminatedOther
Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patients gastrointestinal tract.
- 2010-10-19TerminatedOther
Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.
- 2009-09-01TerminatedProcess control
Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
- 2009-07-21TerminatedProcess control
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
The wire control port of these devices may be missing due to omission of a manufacturing activity.
- 2009-03-10TerminatedProcess control
AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy.
The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
- 2009-01-05TerminatedProcess control
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
The wire control port may have been omitted during manufacture.
- 2008-10-14TerminatedProcess control
Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
A section of the introduction system may detach after the stent has deployed.
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