Endoscope, Accessories, Narrow Band Spectrum
FDA adverse event reports and recall history for endoscope, accessories, narrow band spectrum (product code NWB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 13,648
- Deaths
- 2
- Injuries
- 173
- Malfunctions
- 13,459
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-06-05Open, ClassifiedLabeling design
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number CF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number CF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number PCF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number PCF-H190TL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number PCF-HQ190L.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-29Open, ClassifiedNonconforming Material/Component
Colonoscope, Model Number PCF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
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