Single Use Repositionable Clip HX-202UR (UDI 04953170345203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170345203), received between Nov 5, 2019 and Jan 17, 2024 — classified as 7 injuries, 8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Failure to Fire; Failure to Fire

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE REPOSITIONABLE CLIP PARTIALLY OPENED AND HAD A BIT OF MUCOSA, BUT IT DID NOT DEPLOY WHEN INSIDE THE PATIENT'S COLON. THE ISSUE WAS FOUND DURING A COLONOSCOPY AND POLYPECTOMY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR PROCEDURAL DELAY. DURING THE LEGAL MANUFACTURER'S EVALUATION, THIS EVENT WAS DETERMINED TO BE A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526262 ↗
• InjuryMar 10, 2023Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526074 ↗
• InjuryMar 10, 2023Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526060 ↗
• InjuryMar 10, 2023Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525998 ↗
• InjuryMar 10, 2023Mechanical Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525636 ↗
• InjuryMar 10, 2023Difficult to Open or Close

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: Foreign Body In Patient

  MAUDE report 16525473 ↗
• InjuryMar 10, 2023Mechanics Altered

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A SINGLE USE REPOSITIONABLE CLIP DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WOULD SEAL AND FIRE BUT WOULD NOT STAY CLOSED ONCE DEPLOYED AFTER THE SURGEON PULLED IT FROM THE MUCOSA. THE CLIP DID FALL INTO THE PATIENT, AND WAS RETRIEVED. A DIFFERENT DEVICE AND FOUR CLIPS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED WHILE THE CIRCULATING NURSE RETRIEVED ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. THREE CLIPS IN TOTAL WERE RETURNED BUT IT WAS UNKNOWN IF ALL THREE WERE USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 20. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 27K 15. PATIENT IDENTIFIER (B)(6) IS FOR CLIP WITH LOT NUMBER 275 15.

  Patient problems: Foreign Body In Patient

  MAUDE report 16525255 ↗
• InjuryAug 30, 2021Use of Device Problem; Use of Device Problem

  IT IS REPORTED BY THE CUSTOMER DURING A GASTROSCOPY PROCEDURE USING A SINGLE USE REPOSITIONABLE CLIP, THE CLIPS WERE SUCCESSFULLY APPLIED, HOWEVER THE CLIP DID NOT DETACH FROM THE COIL. SEQUENCE OF EVENTS AS FOLLOWS: THE PATIENT WAS ADMITTED TO THE LOCAL HOSPITAL BECAUSE OF ANEMIA, THE LIKELY CAUSE BEING GASTROINTESTINAL (GI) BLEEDING. A GASTROSCOPY WAS PERFORMED BY A EXPERIENCED DOCTOR WITH ASSISTANCE FROM AN EXPERIENCED NURSE. THE LIKELY SOURCE OF BLEED WAS LOCATED IN THE DUODENUM (HOWEVER THERE WAS NO ACTIVE BLEEDING AT THAT EXACT POINT). CLIPS WERE APPLIED. THE CLIP DID NOT DETACH FROM THE COIL. THE PHYSICIAN TRIED TO ROTATE THE CLIP, THIS ONLY MADE THE BLEEDING WORSE. THE SCOPE WAS THEN WITHDRAWN FROM THE PATIENT. THE CLIP WITH THE APPLICATOR WERE ALSO WITHDRAWN IN THIS MOTION. THIS MADE THE BLEEDING FAR MORE SEVERE. THE PATIENT WAS THEN TRANSPORTED EMERGENTLY TO THE NEAREST UNIVERSITY HOSPITAL. THE PATIENT HAS SINCE GONE THROUGH 4 GASTROSCOPIES AND HAS RECEIVED NUMEROUS TRANSFUSIONS. THE PATIENT DID SURVIVE AND DOES NOT SEEM TO HAVE SUFFERED FROM PERMANENT COMPLICATIONS DUE TO THIS EVENT. THE LOT NUMBER OF THE DEVICE COULD NOT BE PROVIDED, AND THE DEVICE COULD NOT BE RETURNED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12384865 ↗
• MalfunctionFeb 12, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  THE SERVICE CENTER RECEIVED A CORRESPONDENCE FROM ALBERTA HEALTH CANADA, REPORT AHS MDIP #1220, THAT A SINGLE USE REPOSITIONABLE CLIP FIRED OPEN, WOULD NOT CLOSE AND FELL APART INTO THREE PIECES. THE SCOPE AND CLIP WERE INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. THE SCOPE USED IN THE PROCEDURE WAS AN OLYMPUS PCF H190DL. THE REPORTED INCIDENT OCCURRED WHEN THE PHYSICIAN WAS USING THE CLIP, HX-202UR, LOT NUMBER 96K, FOR A POST POLYPECTOMY. THE ITEMS WERE RETRIEVED FROM THE PATIENT USING BIOPSY FORCEPS AND DISCARDED AS IT WAS REPORTED THE ITEMS WERE IN CONTACT WITH BIOHAZARD MATERIALS. THE DEVICE WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION AS THE ITEMS WERE DISCARDED BY THE USER FACILITY. IT WAS REPORTED THE PATIENT DID NOT HAVE ANY APPARENT INJURY. THE SCOPE WAS INSPECTED AFTER THE PROCEDURE AND NO ABNORMAL OBSERVATIONS WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701943 ↗
• MalfunctionDec 27, 2019Break; Break

  THE SERVICE CENTER RECEIVED A REPORT OF A SINGLE USE REPOSITIONABLE CLIP (HX-202UR) THAT FELL OFF/EARLY DEPLOYMENT DURING A COLONOSCOPY PROCEDURE. IT WAS ORIGINALLY REPORTED THAT THE CLIP, HX-202UR, BROKE OFF INTO THE SCOPE, BUT UPON ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, IT WAS LEARNED THAT THE CLIP DEPLOYED PREMATURELY WHILE THE PHYSICIAN WAS ADVANCING THE DEVICE IN THE SCOPE. THE CLIP DEPLOYED EARLY WHEN THE PHYSICIAN WAS INSERTING THE CLIP IN THE SCOPE AND WAS ADVANCING IT, THE DEVICE STOPPED. THE PHYSICIAN REMOVED THE DEVICE AND OBSERVED THE CLIP HAD FALLEN OFF THE END OF THE DEVICE. UPON RETRIEVAL, THE PHYSICIAN OBSERVED THE CLIP, HX-202UR, WAS STILL IN THE SCOPE AND HAD NOT FALLEN INTO THE PATIENT. THE CLIP WAS SAFELY RETRIEVED BACK OUT OF THE SCOPE. IT WAS REPORTED THERE WAS NO BLOOD LOSS, NO PATIENT INJURY. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527459 ↗
• MalfunctionDec 18, 2019Break; Break

  A REPORT WAS RECEIVED BY THE SERVICE CENTER THAT A QUICK CLIP PRO (HX-202UR) FAILED DURING AN UNSPECIFIED PROCEDURE. IT WAS REPORTED WHEN THE PHYSICIAN UNSHEATHED THE CLIP, IT FELL APART. IT IS UNKNOWN IF THE ITEMS WERE RETRIEVED FROM THE PATIENT. THE UNSPECIFIED PROCEDURE WAS COMPLETED WITH ANOTHER CLIP AND IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490456 ↗
• MalfunctionDec 5, 2019Device Fell; Device Fell

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HX-202UR CLIP CAME APART INSIDE A PATIENT. THE CLIP WENT TO OPEN, DEPLOYED AND DETACHED FROM THE CATHETER EXPOSING THE SPRING. THE DETACHED CLIP WAS RETRIEVED AND THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER CLIP. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9418724 ↗
• MalfunctionNov 8, 2019Failure to Deliver; Failure to Deliver

  2 OF 2. IT WAS REPORTED THAT THE HX-202UR A QUICK CLIP FAILED TO DEPLOY DURING A COLONOSCOPY PROCEDURE. THE CLIP FAILED TO DEPLOY WHEN THE USER WAS TRYING TO CLIP A POLYP SITE. THE DEVICE WAS INSPECTED PRIOR TO USE. NO FRAGMENT OF THE DEVICE WAS INSIDE THE PATIENT AND THEREFORE NO FRAGMENT RETRIEVAL IS NEEDED. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. A POLYP SNARE/BIOPSY WAS USED. THE CURRENT CONDITION OF THE PATIENT IS GOOD AND NO PATIENT HARM OR INJURY WAS REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS NOT ABLE FOR EVALUATION. RELATED COMPLAINTS: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9297886 ↗
• MalfunctionNov 8, 2019Failure to Deliver; Failure to Deliver

  1 OF 2. IT WAS REPORTED THAT THE HX-202UR.A QUICK CLIP FAILED TO DEPLOY DURING A COLONOSCOPY PROCEDURE. THE CLIP FAILED TO DEPLOY WHEN THE USER WAS TRYING TO CLIP A POLYP SITE. THE DEVICE WAS INSPECTED PRIOR TO USE. NO FRAGMENT OF THE DEVICE WAS INSIDE THE PATIENT AND THEREFORE NO FRAGMENT RETRIEVAL IS NEEDED. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. A POLYP SNARE/BIOPSY WAS USED. THE CURRENT CONDITION OF THE PATIENT IS GOOD AND NO PATIENT HARM OR INJURY WAS REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS NOT AVAILABLE FOR EVALUATION. RELATED COMPLAINTS: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9297823 ↗
• MalfunctionNov 5, 2019Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE HX-202UR QUICK CLIP WHEN DEPLOYED, WERE DETACHED TOO EARLY FROM THE SHEATH AND DID NOT GRAB ANY TISSUE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9278526 ↗