Single Use Rotatable Clip Fixing Device HX-201UR-135 (UDI 04953170193040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170193040), received between Apr 26, 2022 and Apr 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Failure to Fire; Break; Failure to Fire

  A USER FACILITY REPORTED TO OLYMPUS THAT FOLLOWING POLYP REMOVAL IN THE RECTUM, DURING A COLONOSCOPY PROCEDURE, AN ATTEMPT WAS MADE TO APPLY A CLIP TO A MUCOSAL BREACH, HOWEVER, THE CLIP DID NOT RELEASE FROM THE APPLICATOR AFTER CLOSURE AND REMAINED ATTACHED TO THE CONTROL WIRE, WHICH BROKE AT THE HANDLE. THE ENDOSCOPE WAS REMOVED, LEAVING THE CLIP WITH THE CONTROL WIRE IN PLACE. THE SCOPE WAS REINSERTED AND THE CLIP FORCIBLY REMOVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING CLIPS FROM A DIFFERENT MANUFACTURER. THE PROCEDURE WAS COMPLETED AFTER A DELAY, CHARACTERIZED AS A FEW MINUTES. THERE WAS NO ADVERSE HEALTH EFFECT TO THE PATIENT THAT OCCURRED, ATTRIBUTED TO THE DELAY. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS. THIS IS REPORT #3 OF 3 DUE TO MULTIPLE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210665 ↗
• MalfunctionApr 26, 2022Break; Failure to Fire; Break; Failure to Fire

  A USER FACILITY REPORTED TO OLYMPUS THAT FOLLOWING POLYP REMOVAL IN THE RECTUM, DURING A COLONOSCOPY PROCEDURE, AN ATTEMPT WAS MADE TO APPLY THE CLIP TO A MUCOSAL BREACH, HOWEVER, THE CLIP DID NOT RELEASE FROM THE APPLICATOR AFTER CLOSURE AND REMAINED ATTACHED TO THE CONTROL WIRE, WHICH BROKE AT THE HANDLE. THE ENDOSCOPE WAS REMOVED, LEAVING THE CLIP WITH THE CONTROL WIRE IN PLACE. THE SCOPE WAS REINSERTED AND THE CLIP FORCIBLY REMOVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING CLIPS FROM A DIFFERENT MANUFACTURER. THE PROCEDURE WAS COMPLETED AFTER A DELAY, CHARACTERIZED AS A FEW MINUTES. THERE WAS NO ADVERSE HEALTH EFFECT TO THE PATIENT THAT OCCURRED, ATTRIBUTED TO THE DELAY. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS. THIS IS REPORT #1 OF 3 DUE TO MULTIPLE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210445 ↗
• MalfunctionApr 26, 2022Break; Failure to Fire; Break; Failure to Fire

  A USER FACILITY REPORTED TO OLYMPUS THAT FOLLOWING POLYP REMOVAL IN THE RECTUM, DURING A COLONOSCOPY PROCEDURE, AN ATTEMPT WAS MADE TO APPLY A CLIP TO A MUCOSAL BREACH, HOWEVER, THE CLIP DID NOT RELEASE FROM THE APPLICATOR AFTER CLOSURE AND REMAINED ATTACHED TO THE CONTROL WIRE, WHICH BROKE AT THE HANDLE. THE ENDOSCOPE WAS REMOVED, LEAVING THE CLIP WITH THE CONTROL WIRE IN PLACE. THE SCOPE WAS REINSERTED AND THE CLIP FORCIBLY REMOVED FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING CLIPS FROM A DIFFERENT MANUFACTURER. THE PROCEDURE WAS COMPLETED WITH A DELAY, CHARACTERIZED AS A FEW MINUTES. THERE WAS NO ADVERSE HEALTH EFFECT TO THE PATIENT THAT OCCURRED, ATTRIBUTED TO THE DELAY. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS. THIS IS REPORT #2 OF 3 DUE TO MULTIPLE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210201 ↗