Endo Paddle Retract 173046Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10884523000771), received between Dec 1, 2016 and Dec 17, 2025 — classified as 3 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, WHEN STARTING TO USE THE PADDLE RETRACTOR THE SHAFT OF THE DEVICE WAS FOUND TO BE BROKEN. THE ISSUE WAS RESOLVED BY TAKING ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828637 ↗
• MalfunctionSep 19, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LIVER RESECTION, THE PADDLE RETRACTOR DEPLOYED BUT BROKE OFF FROM THE SHAFT MIDWAY. THE SHAFT WAS ALSO BENT. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME PRODUCT WITH A DIFFERENT LOT NUMBER 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 23103367 ↗
• MalfunctionMay 14, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS, THE SHAFT WAS BROKEN THEREFORE, IT WAS IMPOSSIBLE TO OPEN THE RETRACTOR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020219 ↗
• MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AN ENDO PADDLE RETRACTOR WAS USED DURING A LAPAROSCOPIC ADRENALECTOMY. DURING ITS USE, THE FABRIC PIECE CAME COMPLETELY OFF OF THE PADDLE, INSIDE OF THE PATIENT. THIS WAS IMMEDIATELY NOTICED BY OPERATIVE STAFF, THE FABRIC WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY, AND THE DEVICE WAS REMOVED FROM THE STERILE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748613 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT DURING GASTRIC BYPASS, INTRA-OPERATIVE TESTING OF THE DEVICE, THE SHAFT CRACKED, LEADING TO INCORRECT DEVICE DEPLOYMENT. THE ISSUE OCCURRED DURING THE REMOVAL OF THE DEVICE FROM PACKAGING. TO RESOLVE THE ISSUE, 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 21525778 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE TESTING OF THE TWO PADDLE RETRACTOR, THE SHAFT CRACKED, LEADING TO INCORRECT DEVICE DEPLOYMENT. THE ISSUE OCCURRED DURING THE REMOVAL OF THE DEVICE FROM PACKAGING FOR A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21365664 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE TESTING OF THE TWO PADDLE RETRACTOR, THE SHAFT CRACKED, LEADING TO INCORRECT DEVICE DEPLOYMENT. THE ISSUE OCCURRED DURING THE REMOVAL OF THE DEVICE FROM PACKAGING FOR A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE. TO RESOLVE THE ISSUE, 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 21364763 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE SHAFT OF THE TWO ENDO PADDLE RETRACTOR BROKE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091438 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE SHAFT OF THE TWO ENDO PADDLE RETRACTOR BROKE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091434 ↗
• MalfunctionOct 3, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER RESECTION PROCEDURE, THE HAND INSTRUMENT WAS USED TO RETRACT THE LIVER, BUT THE SHAFT BROKE. IT WAS NOTED THAT THE SHAFT WAS MORE FRAGILE AND THE FABRIC WAS THINNER THAN BEFORE. ADDITIONALLY, THE METALLIC STRUCTURES BEHIND THE FABRIC WERE VISIBLE, WHICH HAD NOT BEEN NOTICED PREVIOUSLY. ANOTHER HAND INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359673 ↗
• InjuryApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ADRENALECTOMY PROCEDURE, THE SURGEON DISCOVERED RIFTS ON THE LIVER UPON INSERTION DUE TO THE SHARPNESS OF THE BROKEN/CRACKED TUBE SIDE, WHICH HAD A 5 CM CRACK IN THE PADDLE. THE INCISION WAS EXTENDED DUE TO DEVICE ISSUE. THERE WAS AN ANTICIPATED TISSUE LOSS AS A RESULT OF THE EVENT. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONVERTED TO AN OPEN ONE, AND THE SURGEON DECIDED TO WITHDRAW THE PADDLE AND ADDRESS THE RIFTS BY SUTURING.

  Patient problems: Laceration(s); Liver Laceration(s)

  MAUDE report 19207183 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A GALLBLADDER PROCEDURE, THE INSTRUMENT WAS NOT SMOOTH TO SCREW TOGETHER. WHEN THEY INSERTED THE PORT INTO THE ABDOMEN, THE BLUE PADDLE WENT OFF AND FELL INTO THE ABDOMEN. THEY WERE ABLE TO RECOVER IT WITHIN A FEW MINUTES AND CONTINUE WORKING. THE SURGEON FOUND ANOTHER WAY TO UPLIFT THE LIVER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033038 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, BEFORE A LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN THE USER OPENED THE THREE DEVICES, IT WAS BENT. DURING THE PROCEDURE, WHILE INSERTING A NEW DEVICE, THE DEVICE BROKE OFF. NO COMPONENT FALL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18813208 ↗
• MalfunctionJan 24, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON A LAPAROSCOPIC SLEEVE PROCEDURE, WHEN THE NURSE PULLED THE PADDLE INTO THE CANNULA, THE FABRIC OF THE DEVICE RIPPED OFF. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576283 ↗
• MalfunctionJan 24, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE FABRIC OF THE DEVICE RIPPED OFF WHEN IT WAS INSERTED INTO THE CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18575000 ↗
• MalfunctionJan 23, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE FABRIC RIPPED WHEN THE PADDLE WAS PLACED DOWN THE CANNULA. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563721 ↗
• MalfunctionFeb 7, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, ON OPENING OF PRODUCT PACKAGING, THE PADDLE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311645 ↗
• MalfunctionJan 25, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LEFT HEMICOLECTOMY, THE HANDPIECE GOT STUCK IN THE TROCAR PREVENTING THE OPENING AND USE OF THE RETRACTOR. THE DEVICE WAS THEN REMOVED AND REPLACED TO RESOLVE THE ISSUE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241929 ↗
• MalfunctionDec 2, 2022Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE FABRIC TORE OFF DEVICE WHEN LOADING SHEATH FOR THE TWO DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909790 ↗
• MalfunctionDec 2, 2022Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE FABRIC TORE OFF DEVICE WHEN LOADING SHEATH FOR THE TWO DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908529 ↗
• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE FABRIC OF THE PADDLE TORE OFF WHEN INSERTED INTO THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894228 ↗
• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE PADDLE TORE OFF PRODUCT WHEN INSERTED INTO SHEATH. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893858 ↗
• InjuryFeb 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE RETRACTOR IS REMOVED FROM THE CAVITY, IT IS NOTICED THAT A 3 MILLIMETERS, SEMITRANSPARENT, WHITE PLASTIC BUTTON-SHAPED PIECE FROM THE END OF THE RETRACTOR WAS MISSING. THE SURGEON DECIDED TO LEAVE THE MISSING PIECE INSIDE THE PATIENT AFTER ATTEMPTS OF RETRIEVAL.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13559734 ↗
• MalfunctionDec 28, 2021Component Missing; Detachment of Device or Device Component

  PATIENT WAS HAVING A LAPAROSCOPIC PROCEDURE. DURING THE PROCEDURE, AN ENDO PADDLE RETRACTOR WAS BEING USED. WHEN THE PADDLE RETRACTOR WAS REMOVED, IT WAS NOTICED THAT A 3MM PIECE FROM THE END OF IT WAS MISSING. THE PIECE IS A SEMITRANSPARENT WHITE PLASTIC BUTTON-SHAPED PIECE. THE DECISION WAS MADE TO LEAVE THE PIECE IN THE PATIENT AFTER RETRIEVAL COULD NOT BE CONFIRMED AFTER ATTEMPTS. THERE IS CURRENTLY NO APPARENT INJURY TO THE PATIENT RELATED TO THE RETAINED ITEM. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13111386 ↗
• MalfunctionNov 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC SLEEVE PROCEDURE, THE FABRIC CAME OFF OF THE DEVICE WHEN PLACE INTO THE CANNULA OF THE DEVICE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12835837 ↗