Single Use Repositionable Clip HX-202UR (UDI 04953170385940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 04953170385940), received between Feb 28, 2019 and Jan 8, 2025 — classified as 50 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 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-1990-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107358 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED : (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107345 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107272 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107262 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107245 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107213 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106906 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED : (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106697 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106544 ↗
• InjuryJan 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, 5 UNITS OF THE SUBJECT DEVICE HAD NEVER DEPLOYED. THIS RESULTED TO THE DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106535 ↗
• MalfunctionSep 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE SINGLE USE REPOSITIONABLE CLIP TOOK FORCE TO PLACE THE ENDOCLIP. BUT THEN, THE ENDOCLIP COULD NOT BE DETACHED FROM THE BASE. THE ISSUE OCCURRED, DURING A GASTROSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20187160 ↗
• MalfunctionFeb 19, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED, THE SUBJECT DEVICE GRABBED THE TISSUE, BUT IT WOULD NOT DEPLOY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE REPORTER BELIEVED TO BE IN THE DUODENUM. ACCORDING TO THE REPORTER, THE SCOPE WAS NOT OVERLY BENT OR TWISTED, AND THE CLIP CLICKED BUT IT DID NOT DEPLOY. THE PROCEDURE WAS AROUND 15-20 MINUTES. THE CLIP WAS BEING USED TO CONTROL A BLEED. ANOTHER CLIP WAS USED SUCCESSFULLY. THERE WAS A SLIGHT EXTENSION OF THE PROCEDURE, BUT THE PROBLEM DID NOT AFFECT THE OUTCOME. NO PATIENT HARM AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730311 ↗
• MalfunctionFeb 9, 2024No Device Output; No Device Output

  IT WAS REPORTED, THE SINGLE USE REPOSITIONABLE COULD NOT BE UNCLIPPED. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681700 ↗
• MalfunctionFeb 6, 2024Separation Failure; Separation Failure

  IT WAS REPORTED, THE REPOSITIONABLE CLIP DID NOT DEPLOY. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE DEVICE WAS REPORTED TO HAVE FAILED UPON INITIAL USE OUT OF THE BOX. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER ADVISED THAT THERE WAS NO PROCEDURE DELAY, AND THE REPORTED PROBLEM DID NOT AFFECT THE DIAGNOSTIC OUTCOME OF THE PROCEDURE. ANOTHER CLIP WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER DISPOSED OF THE CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655771 ↗
• MalfunctionFeb 5, 2024Separation Failure; Separation Failure

  THE CUSTOMER CONFIRMED THE FIRST CLIP DID NOT DETACH AFTER GRABBING THE TISSUE, THE CLIP DID NOT REOPEN AFTER GRABBING THE TISSUE BY PUSHING THE SLIDER. THE CLIP WAS APPLIED TO THE SIGMOID COLON. THE CUSTOMER ADVISED THERE WAS NO PROCEDURE DELAY, AND THE REPORTED PROBLEM DID NOT AFFECT THE DIAGNOSTIC OUTCOME OF THE PROCEDURE. ANOTHER CLIP WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER DISPOSED OF THE CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18643561 ↗
• 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. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445361 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TWO SINGLE USE REPOSITIONABLE CLIPS COULD NOT BE DEPLOYED DURING THE DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AS THE CLEAR SHEATH WAS BROKEN AT THE PROXIMAL END. THE PROCEDURE WAS PROLONGED BY 15 MINUTES AND RESULTED IN MORE BLOOD LOSS THAN NECESSARY AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CLIP AND THE PATIENT WAS THEN TRANSFERRED FOR OBSERVATION DUE TO THE BLOOD LOSS. RELATED PATIENT IDENTIFIER: (B)(6) SINGLE USE REPOSITIONABLE CLIP (HX-202UR / 37K).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18213634 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TWO SINGLE USE REPOSITIONABLE CLIPS COULD NOT BE DEPLOYED DURING THE DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AS THE CLEAR SHEATH WAS BROKEN AT THE PROXIMAL END. THE PROCEDURE WAS PROLONGED BY 15 MINUTES AND RESULTED IN MORE BLOOD LOSS THAN NECESSARY AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CLIP AND THE PATIENT WAS THEN TRANSFERRED FOR OBSERVATION DUE TO THE BLOOD LOSS. RELATED PATIENT IDENTIFIER: (B)(6) SINGLE USE REPOSITIONABLE CLIP (HX-202UR / 37K).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18213628 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Failure to Eject; Adverse Event Without Identified Device or Use Problem; Failure to Eject

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TWO SINGLE USE REPOSITIONABLE CLIPS COULD NOT BE DEPLOYED DURING THE DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AS THE CLEAR SHEATH WAS BROKEN AT THE PROXIMAL END. THE PROCEDURE WAS PROLONGED BY 15 MINUTES AND RESULTED IN MORE BLOOD LOSS THAN NECESSARY AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CLIP AND THE PATIENT WAS THEN TRANSFERRED FOR OBSERVATION DUE TO THE BLOOD LOSS. RELATED PATIENT IDENTIFIER: (B)(6) SINGLE USE REPOSITIONABLE CLIP (HX-202UR / 37K).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18213577 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TWO SINGLE USE REPOSITIONABLE CLIPS COULD NOT BE DEPLOYED DURING THE DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AS THE CLEAR SHEATH WAS BROKEN AT THE PROXIMAL END. THE PROCEDURE WAS PROLONGED BY 15 MINUTES AND RESULTED IN MORE BLOOD LOSS THAN NECESSARY AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A THIRD CLIP AND THE PATIENT WAS THEN TRANSFERRED FOR OBSERVATION DUE TO THE BLOOD LOSS. RELATED PATIENT IDENTIFIER: (B)(6) SINGLE USE REPOSITIONABLE CLIP (HX-202UR / 37K).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18213570 ↗
• MalfunctionNov 6, 2023Mechanical Jam; Mechanical Jam

  AN OLYMPUS TERRITORY MANAGER REPORTED AN OUT OF THE BOX FAILURE ON BEHALF OF THE CUSTOMER. THE APPLICATOR DID NOT DETACH ON THE SINGLE USE REPOSITIONABLE CLIP. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077019 ↗
• InjurySep 1, 2023Failure to Eject; Failure to Eject

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THREE SINGLE USE REPOSITIONABLE CLIPS FAILED TO DEPLOY PROPERLY DURING A COLONOSCOPY WITH POLYPECTOMY WHILE THE PATIENT WAS BLEEDING CAUSING THE PROCEDURE TO EXTEND BY 20-30 MINUTES, AND EVENTUALLY, CANCELLED. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL TO STOP THE BLEEDING AND THE PATIENT SUBSEQUENTLY UNDERWENT ANOTHER COLONOSCOPY USING THIRD-PARTY CLIPS. THE THREE CLIPS WERE LEFT INSIDE THE PATIENT AND WILL NOT BE RETURNED. THERE WAS NO FURTHER MEDICAL INTERVENTION NEEDED AND NO FURTHER PATIENT IMPACT REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - SINGLE USE REPOSITIONABLE CLIP 1/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 2/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 3/3. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6) .

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17670198 ↗
• InjurySep 1, 2023Failure to Eject; Failure to Eject

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THREE SINGLE USE REPOSITIONABLE CLIPS FAILED TO DEPLOY PROPERLY DURING A COLONOSCOPY WITH POLYPECTOMY WHILE THE PATIENT WAS BLEEDING CAUSING THE PROCEDURE TO EXTEND BY 20-30 MINUTES, AND EVENTUALLY, CANCELLED. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL TO STOP THE BLEEDING AND THE PATIENT SUBSEQUENTLY UNDERWENT ANOTHER COLONOSCOPY USING THIRD-PARTY CLIPS. THE THREE CLIPS WERE LEFT INSIDE THE PATIENT AND WILL NOT BE RETURNED. THERE WAS NO FURTHER MEDICAL INTERVENTION NEEDED AND NO FURTHER PATIENT IMPACT REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - SINGLE USE REPOSITIONABLE CLIP 1/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 2/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 3/3. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6) .

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17670191 ↗
• InjurySep 1, 2023Failure to Eject; Failure to Eject

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THREE SINGLE USE REPOSITIONABLE CLIPS FAILED TO DEPLOY PROPERLY DURING A COLONOSCOPY WITH POLYPECTOMY WHILE THE PATIENT WAS BLEEDING CAUSING THE PROCEDURE TO EXTEND BY 20-30 MINUTES, AND EVENTUALLY, CANCELLED. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL TO STOP THE BLEEDING AND THE PATIENT SUBSEQUENTLY UNDERWENT ANOTHER COLONOSCOPY USING THIRD-PARTY CLIPS. THE THREE CLIPS WERE LEFT INSIDE THE PATIENT AND WILL NOT BE RETURNED. THERE WAS NO FURTHER MEDICAL INTERVENTION NEEDED AND NO FURTHER PATIENT IMPACT REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - SINGLE USE REPOSITIONABLE CLIP 1/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 2/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 3/3. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17670161 ↗
• InjurySep 1, 2023Failure to Eject; Failure to Eject

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THREE SINGLE USE REPOSITIONABLE CLIPS FAILED TO DEPLOY PROPERLY DURING A COLONOSCOPY WITH POLYPECTOMY WHILE THE PATIENT WAS BLEEDING CAUSING THE PROCEDURE TO EXTEND BY 20-30 MINUTES, AND EVENTUALLY, CANCELLED. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL TO STOP THE BLEEDING AND THE PATIENT SUBSEQUENTLY UNDERWENT ANOTHER COLONOSCOPY USING THIRD-PARTY CLIPS. THE THREE CLIPS WERE LEFT INSIDE THE PATIENT AND WILL NOT BE RETURNED. THERE WAS NO FURTHER MEDICAL INTERVENTION NEEDED AND NO FURTHER PATIENT IMPACT REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - SINGLE USE REPOSITIONABLE CLIP 1/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 2/3. (B)(6) - SINGLE USE REPOSITIONABLE CLIP 3/3. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17670151 ↗