Endo Retract 176613Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884523000849), received between Jun 7, 2017 and Feb 3, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY, THE GREEN HANDLE SEPARATED FROM THE LONG SHAFT OF THE RETRACTOR WHILE A RESIDENT WAS ROTATING THE HANDLE TO OPEN THE THREE FINGERS OF THE RETRACTOR TO SUPPORT THE LIVER. IT WAS DIFFICULT TO REMOVE THE RETRACTOR OUT OF THE BELLY THEN BUT THE DEVICE WAS ULTIMATELY REMOVED BY THE ATTENDING PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251898 ↗
• MalfunctionNov 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE WHEN SETTING UP THE INSTRUMENT, WHILE TRYING TO PUT THE INSTRUMENT IN PLACE, THE THREE RETRACTOR HANDLES BROKE AND OPENED IN HALF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640000 ↗
• MalfunctionOct 15, 2024Break; Break

  ACCORDING TO THE REPORTER, WHILE TRYING TO PUT THE INSTRUMENT IN PLACE, THE TWO RETRACTOR HANDLES BROKE AND OPENED IN HALF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451412 ↗
• MalfunctionOct 15, 2024Break; Break

  ACCORDING TO THE REPORTER, WHILE TRYING TO PUT THE INSTRUMENT IN PLACE, THE TWO RETRACTOR HANDLES BROKE AND OPENED IN HALF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451101 ↗
• MalfunctionJul 24, 2024Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED MYOMECTOMY PROCEDURE, THERE WERE SOME NOTCHES ON THE TIP OF THE RETRACTOR THAT THEY COULD NOT SEE WITH NAKED EYES BUT COULD BE NOTICED ON THE MONITOR. THE BOWEL WAS CONSTANTLY GETTING CAUGHT IN THIS, AND THAT WAS ABNORMAL. TO RESOLVE THE ISSUE, A GRASPER WAS USED TO REMOVED THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817495 ↗
• MalfunctionJul 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN EXPLORATION AFTER THE INSTALLATION OF A BYPASS WITH REDUCTION OF THE GASTRIC RESERVOIR, WHEN THE RETRACTOR WAS USED DURING HANDLING, IT CRACKED LENGTHWISE. ANOTHER ONE WAS USED TO RESOLVE THE ISSUE. THERE WAS A LOSS OF TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665894 ↗
• MalfunctionMar 21, 2024Difficult to Remove; Mechanics Altered; Difficult to Remove; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THORACIC SURGERY, WHEN THE DEVICE WAS USED, IT WAS WORKING WELL UNTIL, WHEN THE SURGEON WAS TRYING TO CLOSE THE FAN TO PULL IT OUT, THE FAN WOULD NOT CLOSE. TO RESOLVE THE ISSUE, THE SURGEON HAD TO FORCE THE FAN TO CLOSE USING AN INSTRUMENT SO THE SURGEON COULD GET IT OUT OF THE PORT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955940 ↗
• MalfunctionNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE HANDLE SNAPPED OFF WHILE IN USE. THERE WAS NO UNDUE FORCE WAS USED. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847907 ↗
• MalfunctionOct 13, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FOR TUBULAR STOMACH AND OBESITY GRADE 3, WHILE HOLDING OF THE LIVER, THE RETRACTOR BROKE. A REUSABLE SURGICAL SLEEVE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15601139 ↗
• MalfunctionMay 12, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HARTMANN PROCEDURE WITH A PATIENT THAT HAD A PREOPERATIVE RADIOTHERAPY, IN DISSECTING THE PELVIC, ON THREE DEVICES, THE SURGEON NOTICES THAT THE LATEST ITERATIONS (GREEN IN COLOR) ARE NOT AS ROBUST AS WHAT THE SURGEON REMEMBERS THEM. THE DEVICES FEEL ARE FAR TOO FLIMSY. THE DEVICES RETRACT FINE WITH GENTLE PRESSURE, BUT WHEN USED IN THE MALE PELVIS A BIT OF FORCE WAS NEEDED. THE DEVICES WERE USED FOR DECENT LEVERAGE AGAINST THE MESORECTUM AND BONY SIDE WALL, TO GET A PROGRESSIVE VIEW, AND FOR COUNTER TRACTION. THE THREE-BLADED RETRACTOR TENDS TO SNAP BETWEEN THE SHAFT AND THE HAND GRASP AREA (WHERE IT IS GREEN). THE FIVE FINGER RETRACTOR AREA ANGULATES, AND IT TENDS TO SNAP AT THE ANGULATED JUNCTION OF THE BLADE BEFORE IT SNAPS AT THE GREEN AREA TOO. TO RESOLVE THE ISSUE, THE SURGEON NEEDED TO USE THREE DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380447 ↗
• InjuryDec 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RETRACTION ON A LAPAROSCOPIC NEPHRECTOMY, A PIECE OF THE DEVICE¿S FINGER FELL INTO THE PATIENT¿S CAVITY AND ONLY DISCOVERED WHEN THE PROCEDURE WAS CONVERTED TO OPEN. THE SURGEON REMOVED THE COMPONENT THAT FELL INTO THE CAVITY BY USING HAND.

  Patient problems: No Information

  MAUDE report 9401223 ↗
• MalfunctionDec 6, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, A PIECE OF THE EQUIPMENT HAD BECOME DETACHED FROM THE INSTRUMENT, AND WAS RETRIEVED USING A GRASPER AND REMOVED FROM THE SURGICAL AREA. THE DEVICE RETRACTOR WAS IMMEDIATELY REMOVED FROM SURGERY, BAGGED, BROKEN PIECE WAS PLACED IN A SPECIMEN POT AND INTO BAG. A NEW INSTRUMENT WAS OPENED IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089552 ↗
• MalfunctionNov 30, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A RADICAL PROSTATECTOMY PROCEDURE, AT THE BEGINNING OF THE SURGICAL PROCEDURE, A PIECE OF DEVICE WAS LOST INSIDE PATIENT'S INTRAOPERATIVE SPACE. THE OPERATOR SAW IT AND REMOVED IT FROM THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073499 ↗
• MalfunctionSep 8, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC NEPHRECTOMY. THERE WAS SOMETHING BLACK NOTICED INSIDE THE PATIENT. THE SURGEON REMOVED THE FOREIGN MATERIAL, WHICH WAS A COMPONENT OF THE RETRACTING TOOL BEING USED. THE DEVICE WAS EXAMINED TO ENSURE THAT ALL DISENGAGED COMPONENTS WERE REMOVED FROM THE PATIENT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851222 ↗
• InjuryJun 7, 2017Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available; Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER PER ADDITIONAL INFORMATION RECEIVED BOTH BLADES WERE RETRIEVED FROM THE PATIENT. THEY WERE REMOVED VIA THE LAPAROSCOPIC PORTS THAT WERE ALREADY IN SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6619878 ↗
• InjuryJun 7, 2017Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available; Detachment Of Device Component; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC NEPHRECTOMY, TWO ENDO RETRACTS HAVE FAILED AND COME APART INSIDE THE PATIENT. THE BLADES FELL AND HAD TO FIND THE MISSING PIECES. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE INCISION WAS ALSO EXTENDED FOR MORE THAN 1 INCH. PATIENT STATUS: ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6619841 ↗