Laparoscopic Accessories, Gynecologic

Reports per year

Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2016-01-30TerminatedPackaging process control

  PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.

  Damage to package seals potentially compromising sterility.

• 2013-06-07TerminatedNonconforming Material/Component

  Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

  Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;

• TerminatedUnder Investigation by firm

  Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

  There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

• TerminatedUnder Investigation by firm

  Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

  There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

• TerminatedUnder Investigation by firm

  DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620

  There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

• TerminatedUnder Investigation by firm

  Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)

  There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.

• TerminatedLabeling design

  Clarke-Reich Laparoscopic Knot Pusher

  reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products