Single Use Rotatable Clip Fixing Device HX-201UR-135 (REF N4541030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170353123), received between May 19, 2022 and Apr 5, 2024 — classified as 1 death, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 23, 2023Class IIOpen, Classified

   There have been complaints that the clip did not come out of the tube sheath during the procedure.

   Z-1418-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19053566 ↗
• MalfunctionJul 11, 2023Ejection Problem; Ejection Problem

  A CUSTOMER REPORTED TO OLYMPUS DURING A THERAPEUTIC COLONOSCOPY, THE SINGLE USE ROTATABLE CLIP FIXING DEVICE WOULD NOT DEPLOY PROPERLY FROM THE INSERTION WIRE WHEN TRIGGER WAS PULLED. THE CLIP DID NOT ATTACH TO THE TISSUE AT THE TREATMENT SITE. A SECOND CLIP FELL OFF INTO THE SCOPE CHANNEL. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297551 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171912 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER: 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171798 ↗
• MalfunctionAug 4, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6), REPORT WITH PATIENT IDENTIFIER (B)(6), REPORT WITH PATIENT IDENTIFIER (B)(6), THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15171650 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161619 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161610 ↗
• MalfunctionAug 3, 2022Separation Failure; Activation, Positioning or Separation Problem; Separation Failure; Activation, Positioning or Separation Problem

  CUSTOMER REPORTED AN OUT OF BOX FAILURES FOR THREE HX-201UR-135-A DEVICE WITH LOT NUMBER 17V 01 . DEVICE WAS REPORTED TO FAIL UPON INITIAL USE (THERAPEUTIC). THE QUICKCLIPS WOULD ATTACH TO TISSUE, BUT WOULD NOT DETACH FROM THE WIRE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS EVENT INCLUDES THREE (3) REPORTS TO ACCOUNT THE THREE DEVICES FAILED THAT CUSTOMER REPORTED. REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). REPORT WITH PATIENT IDENTIFIER (B)(6). THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161603 ↗
• MalfunctionJun 10, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC POLYPECTOMY PROCEDURE WHILE ATTEMPTING TO CLOSE THE SITE POST POLYPECTOMY, THE DEVICE WAS CLOSED ONTO THE TISSUE. HOWEVER, THE DEVICE CLIP WAS NOT ABLE TO RELEASE AND BE DEPLOYED. THE DRIVE WIRE INSIDE THE HANDLE WAS BUCKLING OUT OF THE HANDLE. THE CLIP HAD TO BE REMOVED BY FORCE FROM THE TISSUE AND THE DEVICE REMOVED. THE PROCEDURE WAS COMPLETED BY USING DEVICE FROM MIROCTECH BRAND. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PATIENT OUTCOME WAS NORMAL AND AS EXPECTED. CUSTOMER REQUEST A REPLACEMENT OF THE ENTIRE BATCH OF THE DEVICE OWNED BY THE CUSTOMER WITH DEVICES FROM OTHER BATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655846 ↗
• MalfunctionMay 19, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED CLIP IS ADHERING TO THE MUCOSA BUT DOES NOT RELEASE FROM THE INDUCTION DEVICE. ACCORDING TO THE REPORTER, THE USER WAS ATTEMPTING TO USE THE QUICK CLIP IN AN AREA WHERE THE POLYP WAS REMOVED. THE INTENDED PROCEDURE (COLONOSCOPY) WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM OR INJURY TO THE PATIENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14441044 ↗