Single Use Repositionable Clip HX-202UR (UDI 04953170385933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170385933), received between Oct 4, 2018 and May 22, 2025 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. May 4, 2023Class IIOpen, Classified

   Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

   Z-1989-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE SUBJECT DEVICE FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE AND THERE WERE NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074917 ↗
• MalfunctionMay 3, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED, THAT SHE HAD THREE OLYMPUS SINGLE-USE REPOSITIONABLE CLIPS DEPLOYED. BUT THEY DID NOT STAY ATTACHED TO THE BLEEDING SPOT IN THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THIS EVENT TOOK PLACE DURING A DIAGNOSTIC COLONOSCOPY WITH A POLYPECTOMY PROCEDURE. REPORTEDLY, THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 15 MINUTES, DUE TO ATTEMPTING THE SECOND TWO CLIPS. THE INITIAL REPORTER CONFIRMED, THAT THE PROCEDURE WAS COMPLETED, FOLLOWING THE ATTEMPT OF THE THIRD CLIP AS THE BLEEDING WAS STOPPED. THIS IS REPORT 3 OF 3. FOR DETAILS RELATED TO THE REMAINING 2 CLIPS. PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860780 ↗
• MalfunctionMay 3, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT SHE HAD THREE OLYMPUS SINGLE-USE REPOSITIONABLE CLIPS DEPLOYED BUT THEY DID NOT STAY ATTACHED TO THE BLEEDING SPOT IN THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THIS EVENT TOOK PLACE DURING A DIAGNOSTIC COLONOSCOPY WITH A POLYPECTOMY PROCEDURE. REPORTEDLY, THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 15 MINUTES DUE TO ATTEMPTING THE SECOND TWO CLIPS. THE INITIAL REPORTER CONFIRMED THAT THE PROCEDURE WAS COMPLETED FOLLOWING THE ATTEMPT OF THE THIRD CLIP AS THE BLEEDING WAS STOPPED. THIS IS REPORT 2 OF 3. FOR DETAILS RELATED TO THE REMAINING 2 CLIPS, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS (B)(6) & (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860706 ↗
• MalfunctionMay 3, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT SHE HAD THREE OLYMPUS SINGLE-USE REPOSITIONABLE CLIPS DEPLOYED BUT THEY DID NOT STAY ATTACHED TO THE BLEEDING SPOT IN THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THIS EVENT TOOK PLACE DURING A DIAGNOSTIC COLONOSCOPY WITH A POLYPECTOMY PROCEDURE. REPORTEDLY, THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 15 MINUTES DUE TO ATTEMPTING THE SECOND TWO CLIPS. THE INITIAL REPORTER CONFIRMED THAT THE PROCEDURE WAS COMPLETED FOLLOWING THE ATTEMPT OF THE THIRD CLIP AS THE BLEEDING WAS STOPPED. THIS IS REPORT 1 OF 3. FOR DETAILS RELATED TO THE REMAINING 2 CLIPS, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS (B)(6) & (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860653 ↗
• MalfunctionSep 1, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CLIP (SUBJECT DEVICE) WAS USED PAST ITS EXPIRATION DATE. THE PRODUCT EXPIRED IN JUNE 2022. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. THE CUSTOMER REQUESTED A COPY OF THE INSTRUCTION MANUAL FOR THE DEVICE. THREE MORE DOCUMENTED ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336424 ↗
• MalfunctionFeb 28, 2020Break; Misfire; Break; Misfire

  THE SERVICE CENTER RECEIVED A REPORT OF A SINGLE USE REPOSITIONABLE CLIP (HX-202UR), LOT NUMBER 97K, THAT MISFIRED INSIDE A SCOPE. IT IS UNKNOWN IF THE QUICK CLIP, HX-202UR, AND THE SCOPE WERE INSPECTED PRIOR TO THE UNSPECIFIED PROCEDURE. IT WAS REPORTED THE CLIP MISFIRED WHILE INSIDE THE SCOPE AND THE PIECES FELL INTO THE PATIENT. THE PHYSICIAN RETRIEVED THE PIECES AND IT WAS REPORTED THERE WAS NO PATIENT INJURY. THE SCOPE WAS LEAK TESTED AND PASSED. IT WAS REPORTED THE SCOPE WILL BE RETURNED TO THE SERVICE CENTER TO BE VERIFIED AND EVALUATION FOR ANY DAMAGE DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771185 ↗
• MalfunctionDec 17, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT ONE CLIP THAT FAILED DURING A PROCEDURE. THE QUICK CLIP PRO WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN WAS PLACING THE CLIP DURING AN ESOPHAGO-GASTRO-DUODENOSCOPY, IN THE AREA IN WHICH A 9 MM POLYP WAS RESECTED. THE CLIP FELL APART AND THAT PORTION (SPRING)WAS NOT RETRIEVED FROM THE PATIENT. IT WAS REPORTED ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9484412 ↗
• MalfunctionDec 17, 2019Break; Break

  THE SERVICE CENTER RECEIVED A REPORT OF A QUICK CLIP, HX-202 UR, MALFUNCTION DURING AN UNSPECIFIED PROCEDURE. THE CLIP AND SPRING BROKE APART AND FELL INSIDE A PATIENT. IT IS UNKNOWN IF AND HOW THE ITEMS WERE RETRIEVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SIMILAR DEVICE AND IT WAS REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482126 ↗
• MalfunctionDec 5, 2019Device Fell; Device Fell

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HX-202UR QUICKCLIP WAS DISCONNECTED PREMATURELY FROM THE SHEATH AND A SPRING FROM THE CLIP FELL INTO THE PATIENT. THE USER WAS ABLE TO RETRIEVE THE SPRING AND THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415958 ↗
• MalfunctionNov 12, 2019Device Fell; Device Fell

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, CUSTOMER HAD AN ISSUE WITH THE CLIP. THE CLIP FELL INTO THE PATIENT. THE PROCEDURE WAS PROLONGED DUE TO THE ISSUE, HOWEVER, THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9312415 ↗
• MalfunctionNov 12, 2019Device Fell; Device Fell

  IT WAS REPORTED THAT THE CLIP FELL INTO THE PATIENT DURING AN UNSPECIFIED PROCEDURE. THE 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 9312358 ↗
• MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED THAT DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE, THE DEVICE REPORTEDLY MISFIRED AND MULTIPLE PIECES OF THE CLIP BROKE OFF AND FELL INSIDE THE PATIENT'S COLON. THE DOCTOR RETRIEVED MOST OF THE BROKEN CLIP FRAGMENTS, HOWEVER, THERE WAS ONE PIECE OF THE CLIP THAT WAS NOT RETRIEVED. THE FACILITY DID NOT SEEM TOO CONCERNED AS THEY STATED THEY LEAVE CLIPS IN THE COLON ALL THE TIME AND THAT THE PIECE OF THE CLIP WILL PASS THROUGH THE PATIENT NATURALLY. THE TECHNICIAN IMMEDIATELY DISCARDED THE DEVICE AND OPENED ANOTHER THAT DEPLOYED WITHOUT INCIDENT. THE CHARGE NURSE INDICATED THE TECHNICIAN WAS NOT AS FAMILIAR WITH THE CLIPS AND NOTICED THE TECHNICIAN DID NOT ADVANCE THE CLIP TO THE END OF THE SHEATH WHEN HANDING IT TO THE PHYSICIAN. HOWEVER, IT WAS UNKNOWN IF IT WAS A FAULTY CLIP OR THE TECHNICIAN'S HANDLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9156264 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED THAT DURING THE MIDDLE OF A COLONOSCOPY WITH POLYPECTOMY PROCEDURE, THE ENTIRE CLIP FELL INTO THE PATIENT'S COLON. THE CLIP WAS PASSED THROUGH A NON-OLYMPUS SCOPE AND WHEN THE SHEATH WAS PULLED BACK THE ENTIRE CLIP FELL OFF INTO THE COLON. THE CLIP HAD NOT TOUCHED ANY TISSUE. THE CLIP FELL IN AN OPEN POSITION BUT THEY WERE ABLE TO SNARE THE CLIP AND THE CLIP WAS REMOVED INTACT USING THE SCOPE. THE LEAD RN STATED THERE WAS NOT ANY RESTRICTION WITHIN THE CHANNEL. THERE WAS MINIMAL DELAY, AND OTHER CLIPS WERE USED WITHOUT PROBLEMS TO COMPLETE THE INTENDED PATIENT TREATMENT AS PLANNED. THE SCOPE AND CLIP WERE INSPECTED PRIOR TO PROCEDURE PER PROTOCOL WITHOUT ANY ABNORMALITIES. THERE WAS NO UNEXPECTED BLEEDING FROM THE PATIENT AND THERE WAS NO EXTRA MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124451 ↗
• InjurySep 26, 2019Activation Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A THIRD CLIP FAILED TO DEPLOY AND WHEN RETRIEVING THE CLIP IT CAUSED A TEAR TO THE PATIENT¿S MUCOSA, WITH BLEEDING. THE BLEEDING WAS CONTROLLED WITH AN UNKNOWN DEVICE. IT WAS REPORTED THAT THE END USER HAD EXPERIENCED DEPLOYMENT ISSUES WITH TWO CLIPS PRIOR TO THE INCIDENT AND THESE CLIPS WERE NOT USED ON THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A COMPETITOR¿S DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 9124207 ↗
• InjurySep 26, 2019Firing Problem; Firing Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A THIRD CLIP FAILED TO DEPLOY AND WHEN RETRIEVING THE CLIP IT CAUSED A TEAR TO THE PATIENT¿S MUCOSA, WITH BLEEDING. THE BLEEDING WAS CONTROLLED WITH AN UNKNOWN DEVICE. IT WAS REPORTED THAT THE END USER HAD EXPERIENCED DEPLOYMENT ISSUES WITH TWO CLIPS PRIOR TO THE INCIDENT AND THESE CLIPS WERE NOT USED ON THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A COMPETITOR¿S DEVICE.

  Patient problems: Tissue Damage

  MAUDE report 9124180 ↗
• MalfunctionSep 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED THAT DURING A COLONOSCOPY WITH POLYPECTOMY, THE CLIP WAS PASSED THROUGH THE SCOPE AND WHEN THE SHEATH WAS PULLED BACK THE ENTIRE CLIP FELL OFF INTO THE COLON OF THE PATIENT. IT HAD NOT EVEN TOUCHED ANY TISSUE. THE CLIP FELL OFF IN AN OPEN POSITION. THE STAFF WAS ABLE TO SNARE THE CLIP AND REMOVE THE CLIP INTACT FROM THE PATIENT. THERE WAS NO DEATH OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104611 ↗
• MalfunctionAug 8, 2019Break; Break

  SERVICE CENTER WAS INFORMED THAT DURING A PROCEDURE THE QUICKCLIP "EXPLODED" (BROKE APART) INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875005 ↗
• MalfunctionAug 7, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT WHEN THE PHYSICIAN DEPLOYED THE CLIP THE PART OF THE SPRING MECHANISM DEPLOYED WITH THE CLIP AND CLIP FELL OFF INTO THE PATIENT. THE USER USED THE ANOTHER CLIP BECAUSE THE ARMS WERE BENT ON THE FIRST CLIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8870944 ↗
• MalfunctionJul 16, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT WHEN THE CUSTOMER DEPLOYED A CLIP, THE CLIP OPENED AND FELL APART IN TWO PIECES. THE CUSTOMER WAS ABLE TO RETRIEVE ONE OF THE PIECES FROM THE PATIENT. THE OTHER PIECE WAS LEFT AND APPEARED TO BE THE END OF THE CLIP WHERE IT SEPARATES/ DEPLOYS. THE PROCEDURE WAS COMPLETED USING A SIMILAR CLIP WITHOUT ANY ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794595 ↗
• MalfunctionApr 30, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE DETACHED AND FELL OFF INTO THE PATIENT; SPRING INCLUDED. THE ITEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER CLIP WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8567545 ↗
• MalfunctionApr 28, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A POLYPECTOMY PROCEDURE, WHILE THE DOCTOR WAS REMOVING THE POLYP THE CLIP AND IT¿S SPRING BROKE OFF AND FELL INTO THE PATIENT. THE DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED USING ANOTHER CLIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8559665 ↗
• MalfunctionJan 3, 2019Failure to Fire; Failure to Fire

  OLYMPUS WAS INFORMED THAT TOWARDS THE END OF A COLONOSCOPY PROCEDURE, THE CLIP WAS CLOSED ONTO A POLYP WITHIN THE SIGMOID COLON TISSUE, BUT THE CLINICIAN COULD NOT IMMEDIATELY DETACH THE CLIP FROM THE REST OF THE CLIP DEVICE. THE CLIP EVENTUALLY WAS DETACHED AFTER A PROCEDURE DELAY OF 13 TO 15 MINUTES. THE PATIENT HAD NO REPORTED ADDITIONAL BLEEDING OR INJURY. BOTH THE CLIP DEVICE AND THE OLYMPUS PCF-Q180 ENDOSCOPE USED WITH THE CLIP HAD BEEN INSPECTED PRIOR TO USE, WITH NO ANOMALIES FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8215602 ↗
• MalfunctionOct 4, 2018Positioning Problem; Positioning Problem

  OLYMPUS WAS INFORMED THAT DURING THE MIDDLE OF A COLONOSCOPY PROCEDURE, THE CLIP HAD A ¿REPOSITIONING PROBLEM¿ AS THE CLIP FELL INTO THE PATIENT¿S CECUM. THE CLIP WAS EXTENDED OUT OF THE SHEATH ON THE FIRST ATTEMPT AND UPON ADVANCING THE CLIP, IT IMMEDIATELY FELL OUT OF THE SHEATH. THE CLIP WAS SEEN IN THE PATIENT¿S CECUM WITH THE METAL SHEATHING MISSING, EXPOSING THE SPRING OF THE CLIP. THE PHYSICIAN WAS USING SUCTION ON THE COLONOSCOPE WHEN IT BECAME OBSTRUCTED. THE CLOGGED COLONOSCOPE WAS REMOVED FROM THE PATIENT AND A NEW COLONOSCOPE WAS INSERTED. THE CLIP WAS REMOVED FROM THE PATIENT¿S CECUM BY USING BIOPSY FORCEPS AND REMOVING THE COLONOSCOPE. A NEW CLIP WAS APPLIED TO THE CECAL POLYP SITE AND THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED TO GO HOME WITH NO COMPLICATIONS. THE METAL SHEATH WAS LATER REMOVED FROM THE COLONOSCOPE¿S SUCTION CHANNEL BY THE USE OF A CLEANING BRUSH. THE METAL SHEATH WAS FOUND IN TWO PIECES. NO ISSUES WERE FOUND WITH THE COLONOSCOPE DURING REPROCESSING. THE PROCEDURE WAS DELAYED OVER FIFTY-TWO MINUTES. THERE WAS NO UNEXPECTED BLEEDING OR TISSUE TRAUMA REPORTED. THE USER FACILITY REPORTED THE CLIP WAS NOT OPENED PRIOR T

  Patient problems: Foreign Body In Patient

  MAUDE report 7934815 ↗