Single Use Repositionable Clip HX-202UR (UDI 04953170345180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 04953170345180), received between Jul 11, 2018 and Feb 13, 2026 — classified as 16 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Difficult to Open or Close

  IT WAS REPORTED THE SINGLE USE REPOSITIONAL CLIP GOT STUCK AND THERE WAS NO WAY TO RELEASE IT. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTROSCOPY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333120 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 22902766 ↗
• InjurySep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ONCE THE CLIP DELIVERY SYSTEM WENT THROUGH THE SCOPE AND INTO THE COLON, THE CLIP JUST FELL OFF THE DELIVERY SYSTEM WITHOUT DEPLOYING THE CLIP. THE CUSTOMER LATER REPORTED THAT THE CLIP FELL INTO THE PATIENT AND WAS RECOVERED WITHOUT ANY INJURY OR HARM. THE PROCEDURE BEING PERFORMED WAS A COLONOSCOPY, WHICH WAS COMPLETED SUCCESSFULLY WITH A COMPETITOR PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252788 ↗
• MalfunctionJan 16, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED TO OLYMPUS, THAT THE SINGLE USE REPOSITIONABLE CLIP DID NOT DETACH FROM THE APPLICATOR AFTER IT WAS APPLIED TO THE WOUND. THE ISSUE WAS FOUND DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522353 ↗
• MalfunctionJan 12, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED TO OLYMPUS, THAT THE SINGLE USE REPOSITIONABLE CLIP DID NOT DETACH FROM THE APPLICATOR DURING A COLONOSCOPY. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507600 ↗
• MalfunctionJan 5, 2024Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED TO OLYMPUS, THAT THE SINGLE USE REPOSITIONABLE CLIP WAS CLOSED AND WOULD NOT DEPLOY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455407 ↗
• MalfunctionJan 4, 2024Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE REPOSITIONAL CLIP WAS DEFECTIVE. THE CLIP BENT AND WOULD NOT CLOSE OR DEPLOY. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446800 ↗
• MalfunctionJan 4, 2024Failure to Fire; Failure to Fire

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE REPOSITIONABLE CLIP DID NOT DEPLOY. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443431 ↗
• InjuryDec 4, 2023Failure to Eject; Failure to Eject

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THE POLYPECTOMY THE DOCTOR COULD NOT RELEASE THE CLIP AFTER SEVERAL ATTEMPTS. THE MECHANISM THAT RELEASED THE CLIP WAS NOT WORKING. THE CLIP WAS LOST INSIDE THE PATIENT AND COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18264104 ↗
• MalfunctionNov 22, 2023Failure to Disconnect; Failure to Disconnect

  THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER C23455374.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193875 ↗
• MalfunctionNov 14, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC RESECTION OF A RECTAL NEUROENDOCRINE TUMOR, THE SINGLE USE REPOSITIONABLE CLIP COULD NOT BE RELEASED. THE DEVICE WAS EXCHANGED AND THERE WAS AN INCREASE IN ANESTHESIA AND PROCEDURE TIME BY LESS THAN 15 MINUTES. NO ADDITIONAL TREATMENT WAS NEEDED, NO PROLONGED HOSPITALIZATION, AND NO CONSEQUENCES TO THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136999 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  A CUSTOMER REPORTED TO OLYMPUS THAT WHILE TRYING TO "SHOOT" A SINGLE USE REPOSITIONABLE CLIP, THE APPLICATOR WAS STUCK ON THE CLIP. WHEN IT WAS PULLED BACK, THE CLIP WAS PULLED OUT OF THE WOUND AGAIN. THE CUSTOMER STATED THIS HAS NOT HAPPENED PRIOR, BUT OCCURRED WITH THREE DIFFERENT CLIP APPLICATORS. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING LOT INFORMATION, BUT NOT RECEIVED. THIS EVENT REQUIRES 3 REPORTS FOR THE 3 DIFFERENT CLIP APPLICATORS. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #1. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #2. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #3. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062357 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  A CUSTOMER REPORTED TO OLYMPUS THAT WHILE TRYING TO "SHOOT" A SINGLE USE REPOSITIONABLE CLIP, THE APPLICATOR WAS STUCK ON THE CLIP. WHEN IT WAS PULLED BACK, THE CLIP WAS PULLED OUT OF THE WOUND AGAIN. THE CUSTOMER STATED THIS HAS NOT HAPPENED PRIOR, BUT OCCURRED WITH THREE DIFFERENT CLIP APPLICATORS. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING LOT INFORMATION, BUT NOT RECEIVED. THIS EVENT REQUIRES 3 REPORTS FOR THE 3 DIFFERENT CLIP APPLICATORS. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #1. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #2. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #3. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062347 ↗
• MalfunctionNov 2, 2023Failure to Fire; Failure to Fire

  A CUSTOMER REPORTED TO OLYMPUS THAT WHILE TRYING TO "SHOOT" A SINGLE USE REPOSITIONABLE CLIP, THE APPLICATOR WAS STUCK ON THE CLIP. WHEN IT WAS PULLED BACK, THE CLIP WAS PULLED OUT OF THE WOUND AGAIN. THE CUSTOMER STATED THIS HAS NOT HAPPENED PRIOR, BUT OCCURRED WITH THREE DIFFERENT CLIP APPLICATORS. ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING LOT INFORMATION, BUT NOT RECEIVED. THIS EVENT REQUIRES 3 REPORTS FOR THE 3 DIFFERENT CLIP APPLICATORS. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #1. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #2. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #3. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062315 ↗
• InjuryOct 26, 2023Failure to Eject; Failure to Eject

  THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE EVENT WAS RECEIVED: THE CLIP (HX) WAS OBSERVED TO BE IN A ¿STRAIGHT¿ SHAPE WHEN COMING OUT OF THE ENDOSCOPIC FORCEPS STOPPER. ALTHOUGH IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE CLIP, THE SLIDER PROTRUDED AS A RELEASE ACTION; IT WAS ALSO STATED THAT THE CLIP COULD NOT BE REMOVED. WHEN THE CLIP WAS PLACED, THE USER DID NOT PULL THE SLIDER UNTIL A ¿CLUNK¿ WAS HEARD.

  Patient problems: Foreign Body In Patient; Laceration(s); Unspecified Tissue Injury

  MAUDE report 18014599 ↗
• InjuryMar 3, 2023Difficult to Open or Close; Difficult to Open or Close

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS IN BEHALF OF THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE USING THIS SINGLE USE REPOSITIONABLE CLIP, THE CLIP DID NOT REOPEN AFTER GRABBING THE TISSUE AND CAUSED MORE GASTROINTESTINAL BLEEDING. THE ONLY WAY TO REMOVE IT, AS REPORTED WAS TO RIP IT OFF. THE BLEEDING WAS STOPPED USING A COMPETITOR CLIP. THE PROCEDURE WAS DELAYED FOR FIFTEEN (15) MINUTES. NO ADDITIONAL INTERVENTION WAS DONE OTHER THAN MORE HEMOSTASIS THAT WAS NEEDED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 16480032 ↗
• InjuryMar 3, 2023Difficult to Open or Close

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE USING THIS SINGLE USE REPOSITIONABLE CLIP, THE CLIP DID NOT REOPEN AFTER GRABBING THE TISSUE AND CAUSED MORE GASTROINTESTINAL BLEEDING. THE ONLY WAY TO REMOVE IT, AS REPORTED WAS TO RIP IT OFF. THE BLEEDING WAS STOPPED USING A COMPETITOR CLIP. THE PROCEDURE WAS DELAYED FOR FIFTEEN (15) MINUTES. NO ADDITIONAL INTERVENTION WAS DONE OTHER THAN MORE HEMOSTASIS THAT WAS NEEDED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16479828 ↗
• MalfunctionSep 5, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT, DURING REPROCESSING OF THE ENDOSCOPE, A CLIP FELL OUT OF THE ENDOSCOPE. THE ENDOSCOPE HAD PREVIOUSLY BEEN USED IN A POLYPECTOMY PROCEDURE DURING WHICH A CLIP FELL OFF AND DID NOT ATTACH. A SECOND CLIP WAS USED TO COMPLETE THAT PROCEDURE AND THE ENDOSCOPE WAS REPROCESSED AND PLACED BACK IN SERVICE. THE NEXT CASE IN WHICH THE ENDOSCOPE WAS USED DID NOT REQUIRE ANY CLIPS. AFTER THAT PROCEDURE, THE ENDOSCOPE WAS REPROCESSED AND A CLIP FELL OUT DURING REPROCESSING. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355496 ↗
• MalfunctionJul 13, 2022Separation Failure; Separation Failure

  A BIOMEDICAL ENGINEER AT THE USER FACILITY REPORTED THAT TWO SINGLE-USE REPOSITIONABLE CLIPS (SUBJECT DEVICE) WOULD NOT RELEASE WHEN "FIRED". THE CUSTOMER REPORTED THAT THE ISSUE WAS NOT DUE TO MANIPULATION. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICES WERE DISCARDED BY THE USER FACILITY; HOWEVER, PHOTOS OF THE CLIPS WERE PROVIDED. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND CLIP, UNDER PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE FIRST CLIP WAS SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000803 ↗
• MalfunctionJul 13, 2022Separation Failure; Separation Failure

  A BIOMEDICAL ENGINEER AT THE USER FACILITY REPORTED THAT TWO SINGLE-USE REPOSITIONABLE CLIPS (SUBJECT DEVICE) WOULD NOT RELEASE WHEN "FIRED". THE CUSTOMER REPORTED THAT THE ISSUE WAS NOT DUE TO MANIPULATION. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICES WERE DISCARDED BY THE USER FACILITY; HOWEVER, PHOTOS OF THE CLIPS WERE PROVIDED. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST CLIP, UNDER PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE SECOND CLIP IS BEING SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000621 ↗
• MalfunctionJun 24, 2022Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT, DURING A DIAGNOSTIC COLONOSCOPY, A POLYPECTOMY WAS PERFORMED. WHEN PLACING THE CLIP, IT GOT CAUGHT IN THE MUCOSA AND WAS DIFFICULT TO RELEASE. TRACTION WAS APPLIED BACKWARDS UNTIL THE CLIP WAS RELEASED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14804495 ↗
• MalfunctionJun 24, 2022Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT, DURING A DIAGNOSTIC COLONOSCOPY, A POLYPECTOMY WAS PERFORMED. WHEN PLACING THE CLIP, IT GOT CAUGHT IN THE MUCOSA AND WAS DIFFICULT TO RELEASE. TRACTION WAS APPLIED BACKWARDS UNTIL THE CLIP WAS RELEASED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14803186 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED ¿PROPHYLACTIC CLIP CLOSURE FOR MUCOSAL DEFECTS IS ASSOCIATED WITH REDUCED ADVERSE EVENTS AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A PROPENSITY-SCORE MATCHING ANALYSIS¿ PATIENTS EXPERIENCED PERFORATION AND/OR BLEEDING EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-655Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS HX-610-090L. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS HX-202UR. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290Z1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AI. STUDY BACKGROUND AND AIM IT IS UNCLEAR WHETHER PROPHYLACTIC ENDOSCOPIC CLOSURE AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) REDUCES THE RISK OF POSTOPERATIVE ADVERSE EVENTS DUE TO VARIABILITY IN LESION CHARACTERISTICS. THEREFORE, WE CONDUCTED A RETROSPECTIVE STUDY USING PROPENSITY SCORE MATCHING TO EVALUATE THE EFFICACY OF PROPHYLACTIC CLIP CLOSURE IN PREVENTING POSTOPERATIVE ADVERSE EVENTS AFTER COLORECTAL ESD METHODS: THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY INCLUDED 219 COLORECTAL NEOPLASMS WHICH WERE REMOVED BY ESD. THE PATIENTS WERE ALLOCATED INTO THE CLOSURE AND N

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14605021 ↗
• MalfunctionMay 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING AN ENDOSCOPY THAT REQUIRED THE USE OF CLIPS, WHEN USER TRIED TO RELEASE 2 CLIPS THEY WERE TOO HARD AND COULD NOT BE RELEASE. CUSTOMER HAD TO PULL THEM BY FORCE BUT WITHOUT RELEASING THEM FROM THE SHEATH. THE PROCEDURE COULD BE COMPLETED WITHOUT COMPLICATIONS AND ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER THERE WERE NO DAMAGE TO THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14527763 ↗
• MalfunctionMay 26, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CLIP DID NOT DETACH FROM THE APPLICATOR DURING COLONOSCOPY. THE INTENDED PROCEDURE (TO PUT A CLIP AFTER POLYPECTOMY) WAS COMPLETED USING A SIMILAR DEVICE. ALTHOUGH THERE WAS A DELAY DUE TO USER TRIED 2 CLIPS THAT DID NOT WORK AND REPLACING THE CLIPS, THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT (FIRST CLIP ) IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND CLIP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519269 ↗