Endo Mini-Retract 174209Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884523000801), received between May 1, 2018 and Sep 15, 2022 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LIVER RESECTION, ON PREPARATION PRIOR TO THE START OF THE OPERATION, WHEN THE HANDLE OF THE RETRACTOR WAS MOVED, THE CONNECTION PART GOT DAMAGED AND THE TIP BECAME UNABLE TO BE RETURNED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15430348 ↗
• MalfunctionJun 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION, WHILE AT EXCLUSIONS AND RESECTION OPERATION, THE TIP DID NOT STORED IMMEDIATELY AFTER INSERTING AND RETRACTING THE TIP PART TWO OR THREE TIMES. IT SEEMED THAT THE INTERNAL INTERLOCKING PARTS GOT DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578069 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING  LAPAROSCOPIC ADRENALECTOMY, WHILE PREPARING THE DEVICE, WHEN THE SURGEON OPENED THE PRODUCT, THE BASE PART OF THE SHAFT WAS FOUND DISCONNECTED  AND COULD NOT BE USED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549003 ↗
• MalfunctionOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE LEVER DISENGAGED AND THE RETRACT PART AT THE TIP GOT STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10717959 ↗
• MalfunctionJun 17, 2020Difficult to Remove; Retraction Problem; Failure to Advance; Material Twisted/Bent; Difficult to Remove; Retraction Problem; Failure to Advance; Material Twisted/Bent

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC COLECTOMY, THE SLIDE BAR CAME OFF AND THE METAL FITTING AT THE TIP COULD NOT BE TAKEN IN AND OUT, IT COULD NOT BE REMOVED FROM THE TROCAR. AS A SMALL ABDOMINAL LAPAROTOMY IN THE COLON WAS PERFORMED WHICH WAS PART OF THE PROCEDURE, BY USING THE FORCEPS, IT WAS BENT FORCIBLY AND SOMEHOW THE RETRACT PART WAS PUT AWAY, AND IT WAS ABLE TO BE REMOVED FROM THE TROCAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163071 ↗
• MalfunctionJun 8, 2020Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, AFTER USING THE DEVICE, THE TIP WAS ATTEMPTED TO BE RETRACTED HOWEVER, IT LOOKED LIKE THAT THE CONNECTION BETWEEN THE LEVER AND TIP CAME OFF AND THE TIP WOULD NOT RETRACT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127200 ↗
• MalfunctionJun 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE BLACK PART AT THE TIP OF THE RETRACTOR CAME OFF, AND THE PRODUCT WAS UNABLE TO BE USED. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704597 ↗
• MalfunctionJun 7, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC DUODENAL SWITCH, WHILE USING THE DEVICE TO DISSECT A WINDOW POSTERIORLY ON THE DUODENUM NEAR THE PYLORUS THE DEVICE FELL APART. THE EXTENDED TIP FELL INTO THE PATIENT WHEN IT BROKE APART BUT IT WAS RETRIEVED. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679392 ↗
• MalfunctionNov 7, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, AFTER OPENING THE NEW PRODUCT IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE SURGEON ATTEMPTED TO CLOSE ITS TIP TO INSERT IT INTO THE ABDOMINAL CAVITY, THE TIP COULD NOT BE CLOSED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047143 ↗
• MalfunctionSep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC SIGMOIDECTOMY, THE NURSE OPENED THE PACKAGING AND CHECKED THE DEVICE. SLIDE LEVER AND SHAFT WAS FOUND DISENGAGED AND THE TIP WAS NOT BEING ABLE TO PUT IN. THEY USED ANOTHER DEVICE TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7907419 ↗
• MalfunctionJul 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HEPATECTOMY PROCEDURE, THE TIP OF THE DEVICE DID NOT CONNECT WITH HANDLE. THE DEVICE WAS REMOVE FROM THE CAVITY WITH THE TROCAR. THE PATIENT HAD AN INFECTION SO THE DEVICE WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 7654306 ↗
• MalfunctionMay 1, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING ESOPHAGECTOMY, THE TIP OF THE DEVICE WAS NOT INTERLOCKED WITH THE PURPLE SLIDE BUTTON. IT MAY HAVE DISENGAGED WHILE TRYING SEVERAL TIMES. THE TIP OF THE DEVICE WAS SEPARATED DUE TO THE HANDLING OF THE SURGEON. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7477588 ↗