Endo Retract II 176647Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 10884523000856), received between Aug 1, 2016 and Aug 11, 2026 — classified as 28 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (108 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 155 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic procedure, a piece of plastic broke off from the device and fell into the patient¿s cavity. A thorough search in the abdomen and the broken piece was not retrieved. A DATIX was completed however, no x-ray performed as the consultant deemed it a higher risk exposing the patient to an x-ray as per her clinical operation note.

  Patient problems: Foreign Body In Patient

  MAUDE report 50204388 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component; Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065557 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTATE SURGERY, WHEN USING RETRACTOR, THE TIP OF THE INSTRUMENT FELL OFF, AND IT WAS LOCATED AND RETRIEVED USING A CAMERA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847481 ↗
• MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE END OF THE DEVICE BROKE INSIDE THE PATIENT WHILE IT WAS BEING USED TO LIFT THE UTERUS. THE BROKEN DEVICE COMPONENT FELL INTO THE PATIENT'S ABDOMINAL CAVITY. IT WAS NOTED THAT THERE WAS AN EXTENSION OF THE OPERATING TIME TO RECOVER THE BROKEN PIECES FROM THE PATIENT'S ABDOMEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732694 ↗
• InjuryNov 10, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATECTOMY, ON THREE DEVICES, THE PLASTIC COVER THAT SURROUNDS THE FAN¿S PIN THAT ALLOWS THE DEVICE TO FOLD AND ROTATE BROKE OFF. IT THEN FELL INTO THE ABDOMINAL CAVITY WHILE RETRACTING THE BLADDER, RESULTING IN PIECES OF THE RETRACTOR BEING CAUGHT IN THE ABDOMEN. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE NEED TO SEARCH FOR AND RETRIEVE THE DEVICE PIECES FROM THE ABDOMINAL CAVITY. AN X-RAY WAS PERFORMED THE DAY AFTER THE EVENT TO CONFIRM THAT NO PIECES REMAINED INSIDE THE ABDOMINAL CAVITY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23518591 ↗
• InjuryNov 10, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATECTOMY, ON THREE DEVICES, THE PLASTIC COVER THAT SURROUNDS THE FAN¿S PIN THAT ALLOWS THE DEVICE TO FOLD AND ROTATE BROKE OFF. IT THEN FELL INTO THE ABDOMINAL CAVITY WHILE RETRACTING THE BLADDER, RESULTING IN PIECES OF THE RETRACTOR BEING CAUGHT IN THE ABDOMEN. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE NEED TO SEARCH FOR AND RETRIEVE THE DEVICE PIECES FROM THE ABDOMINAL CAVITY. AN X-RAY WAS PERFORMED THE DAY AFTER THE EVENT TO CONFIRM THAT NO PIECES REMAINED INSIDE THE ABDOMINAL CAVITY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23518573 ↗
• InjuryNov 10, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROSTATECTOMY, ON THREE DEVICES, THE PLASTIC COVER THAT SURROUNDS THE FAN¿S PIN THAT ALLOWS THE DEVICE TO FOLD AND ROTATE BROKE OFF. IT THEN FELL INTO THE ABDOMINAL CAVITY WHILE RETRACTING THE BLADDER, RESULTING IN PIECES OF THE RETRACTOR BEING CAUGHT IN THE ABDOMEN. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE NEED TO SEARCH FOR AND RETRIEVE THE DEVICE PIECES FROM THE ABDOMINAL CAVITY. AN X-RAY WAS PERFORMED THE DAY AFTER THE EVENT TO CONFIRM THAT NO PIECES REMAINED INSIDE THE ABDOMINAL CAVITY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23518554 ↗
• MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC KIDNEY REMOVAL, WHEN THE DEVICE WAS BEING USED TO LIFT THE KIDNEY, THE DEVICE¿S FINGERS SNAPPED AND FELL INTO THE PATIENT¿S CAVITY. PLASTIC DEBRIS REMOVED WITHIN THE PATIENT BY USING A GRASPERS AND SUCTION. A NEW RETRACTOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460696 ↗
• InjuryOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, THE BENT PART FELL INTO THE PATIENT'S ABDOMINAL CAVITY AND WAS ABLE TO BE RETRIEVED BY VISUAL CONFIRMATION AND POSTOPERATIVE X-RAYS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23327808 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, WHILE BEING USED TO RETRACT TISSUE, THE DEVICE WAS FOUND TO BE DAMAGED. A SMALL BLACK PIECES WERE BROKE OFF. THE DEVICE WAS REPLACED WITH A NEW ONE BEFORE ANY PART COULD FALL INTO THE PATIENT, AND THE PROCEDURE CONTINUED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302224 ↗
• MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE RETRACTOR WAS USED TO LIFT THE KIDNEY WHEN A PART OF THE FAN RETRACTOR SNAPPED OFF. A SMALL PIECE OF THE FAN RETRACTOR FELL INTO THE CAVITY AND WAS SAFELY RETRIEVED USING OTHER INSTRUMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080715 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, A BLACK PLASTIC DEVICE COMPONENT SNAPPED INSIDE THE PATIENT WHILE WORKING IN A NARROW PELVIS WITH EXCESS PRESSURE. THE PLASTIC PART THAT SNAPPED FELL INTO THE CAVITY OF THE PATIENT AND WAS SUBSEQUENTLY RETRIEVED BY THE SURGEON ON COMPLETED ABDOMINAL WASH OUT. IT WAS NOTED THAT AN X-RAY WAS NOT PERFORMED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976996 ↗
• InjuryAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC DIGESTIVE SURGERY, FRAGMENTS OF PLASTIC FROM THE DEVICE WERE DISSEMINATED IN THE ABDOMINAL CAVITY OF THE PATIENT. THE OPERATING TIME WAS LENGTHENED FOR LESS THAN 30 MINUTES WHILE THE PIECES WERE RECOVERED AND THE RETRACTOR WAS CHANGED. IT WAS NOTED THAT THE INCISION WAS EXTENDED.

  Patient problems: Laceration(s)

  MAUDE report 22889046 ↗
• MalfunctionJul 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, THE JOINT BROKE DURING THE LIFTING OF THE BLADDER. THE BROKEN PLASTIC FRAGMENTS OF THE JOINT FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT. THE INCISION WAS EXTENDED DUE TO THE ISSUE BY NOT MORE THAN ONE INCH. ALL THE PLASTIC DEBRIS WERE RETRIEVED FROM THE PATIENT¿S CAVITY WITH A GRASPER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559433 ↗
• InjuryJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY USING THE FAN RETRACTOR, VARIOUS ITEMS FROM THE SHAFT OF THE PRODUCT FELL INTO THE CAVITY OF THE PATIENT. IT WAS NOTED THAT THE SURGEON RETRIEVED THE FRAGMENTS VIA GRASPERS THROUGH THE PORT. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22288528 ↗
• MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ABDOMINOPERINEAL RESECTION (APR) PROCEDURE, THE DEVICE BROKE WHILST BEING HELD IN POSITION INSIDE PATIENTS ABDOMEN. THE MECHANISM GAVE WAY AND SNAPPED. THE BROKEN DEVICE FALL INTO PATIENT CAVITY AND WAS RETRIEVED WITH NO ISSUE. TO RESOLVE THE ISSUE, A NEW RETRACTOR WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014990 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, PIECES OF PLASTIC FROM THE ENDO RETRACT II FELL INTO THE CAVITY OF THE PATIENT. THE COMPONENT WAS RETRIEVED WITH A CLAMP. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590673 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PARTS OF THE FINGERS OF THE RETRACTOR DISENGAGED.

  Patient problems: Insufficient Information

  MAUDE report 20878638 ↗
• InjuryOct 23, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, DURING RENAL RETRACTION, A PART CALLED A CLEVIS WAS DAMAGED TO THE POINT OF CRACKING, AND THE VISIBLE LEVEL OF THE DEBRIS WAS COLLECTED USING FORCEPS. THE DEVICE WAS CLEANED AND SUCTIONED, BUT IT IS UNKNOWN WHETHER IT WAS COMPLETELY RECOVERED. IT WAS NOTED THAT THE ARTICULATION ANGLE WAS ALMOST STRAIGHT, BUT THE SHAFT ROTATION DIAL WAS ROTATED ABOUT 1/4 TURN AND AN X-RAY WAS PERFORMED. THE PRODUCT WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 20516902 ↗
• MalfunctionOct 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING UROLOGICAL PROCEDURE, THE PLASTIC PROTECTORS OF THE DEVICE JOINT WERE OBSERVED TO HAVE BROKEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473063 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, THE JOINT OF ARTICULATING PART GOT BROKEN AND FELL INTO PATIENT CAVITY. THE COMPONENT WAS RETRIEVED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011520 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL SIGMA RESECTION, ON THE FINAL STAGE OF THE PROCEDURE TO SUPPORT THE PELVIS WHEN CREATING A RECTAL ANASTOMOSIS, WHEN OPENING THE RETRACTOR, THE PLASTIC AROUND THE FINGER OPENING JOINT BROKE INTO FOUR PIECES AND FELL INTO THE PATIENT. WASHING AND SUCTION WERE PERFORMED ON THE PATIENT'S CAVITY TO SEARCH FOR THE BROKEN PLASTIC PARTS, WHICH WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974281 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPY ASSISTED DISTAL GASTRECTOMY, DURING LIVER RESECTION, A DEVICE COMPONENT FELL INTO THE PATIENT¿S ABDOMINAL CAVITY AND WAS RETRIEVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665882 ↗
• InjuryJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PLASTIC COVERING THE ARTICULATING JOINT BROKE OFF WHILE IN USE INSIDE THE PATIENT. TWO PIECES WERE RETRIEVED BUT UNSURE IF REMAINING FRAGMENT/S IN PATIENT. X-RAY AND COMPUTED TOMOGRAPHY (CT) SCAN WERE PERFORMED BUT NO FRAGMENTS COULD BE DETECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19624619 ↗
• InjuryJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WHIPPLE'S PROCEDURE, A FEW PLASTIC PIECES OF THE RETRACTOR DISINTEGRATED INTO THE BODY CAVITY. THE STAFF OPENED A NEW ONE TO COMPARE EXACTLY WHAT IT WAS NEEDED TO RETRIEVE FROM THE BODY CAVITY OF THE PATIENT. IT WAS NOTED THAT IT WAS NOT ABLE TO LOCATE ONE PARTICLE BUT PROCEEDED WITH THE SURGERY, AND THE PATIENT WAS UNDER OBSERVATION. TO RESOLVE THE ISSUE, ANOTHER PRODUCT OF THE SAME CODE WAS USED FOR RETRIEVING THE FALLEN PIECES INTO THE BODY CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19537244 ↗