Single Use Reloadable Clip Applicator HX-810UR (UDI 04953170390739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170390739), received between Aug 15, 2023 and Sep 17, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073681 ↗
• MalfunctionSep 17, 2025Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073413 ↗
• MalfunctionJun 20, 2025Separation Failure; Separation Failure

  IT WAS REPORTED DURING CLIP PLACEMENT THE SHEATH COMES OFF AND THE CLIP ITSELF IS NOT RELEASED THE EVENT WAS REPEATED BOTH THE DAY BEFORE AND ON FRIDAY OUT OF 5 TOTAL CLIP-LAYERS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. REPORT 5 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299142 ↗
• MalfunctionJun 20, 2025Separation Failure; Separation Failure

  IT WAS REPORTED DURING CLIP PLACEMENT THE SHEATH COMES OFF AND THE CLIP ITSELF IS NOT RELEASED THE EVENT WAS REPEATED BOTH THE DAY BEFORE AND ON FRIDAY OUT OF 5 TOTAL CLIP-LAYERS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. REPORT 2 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298782 ↗
• MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697485 ↗
• MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697358 ↗
• MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697291 ↗
• MalfunctionFeb 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OPERATION WIRE HAD DETACHED FROM THE MAIN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697170 ↗
• MalfunctionFeb 4, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED, THE SINGLE USE RELOADABLE CLIP APPLICATOR WHILE TRYING TO "SHOOT", THE APPLICATOR GOT STUCK ON THE CLIP. WHEN IT WAS PULLED BACK, THE CLIP WAS PULLED OUT OF THE WOUND AGAIN. THE CUSTOMER ALSO STATED THIS HAS NOT HAPPENED PRIOR BEFORE BUT OCCURRED WITH THREE DIFFERENT CLIP APPLICATORS. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT REQUIRES 4 REPORTS FOR 4 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. PATIENT IDENTIFIER (B)(6) IS FOR INSTANCE #4. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637742 ↗
• MalfunctionNov 21, 2023Failure to Disconnect; Failure to Disconnect

  THE CUSTOMER REPORTED THE ISSUE WAS DETECTED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE CUSTOMER REPORTED THE PROCEDURE WAS NOT PROLONGED OR DELAYED TO A CLINICALLY RELEVANT EXTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184865 ↗
• MalfunctionNov 21, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE RELOADABLE CLIP APPLICATOR CLIP CAN'T RELEASED BECAUSE THE WIRE CAME LOOSE DURING THE CLIP SETUP. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (POLYPECTOMY) AND DIAGNOSTIC (COLONOSCOPY). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179873 ↗
• MalfunctionNov 7, 2023Failure to Disconnect; Failure to Disconnect

  THE CUSTOMER REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THAT THE TENSIONED CLIP OF THEIR SINGLE USE RELOADABLE CLIP APPLICATOR DEVICE REMAINS ATTACHED TO THE APPLICATOR AFTER FIRING AND DOES NOT COME LOOSE. THERE WAS NO DAMAGE TO THE ENDOSCOPE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089433 ↗
• MalfunctionAug 28, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR WAS NOT DETACHING FROM THE CLIP FIXING DEVICE WHEN TRYING TO CLOSE THE CLIP AND THE INSIDE WIRE CLIP APPLICATOR BREAKS FROM THE HANDLE AND GETS LOOSE AND DOES NOT RELEASE THE CLIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638370 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552294 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED FIVE EVENTS INVOLVING 10 DEVICES. EACH EVENT INVOLVED ONE SINGLE USE DISTAL COVER AND ONE EVIS EXERA III DUODENOVIDEOSCOPE. THIS MDR IS FOR A SINGLE USE RELOADABLE CLIP APPLICATOR. THE OTHER RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552277 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED FIVE EVENTS INVOLVING 10 DEVICES. EACH EVENT INVOLVED ONE SINGLE USE DISTAL COVER AND ONE EVIS EXERA III DUODENOVIDEOSCOPE. THIS MDR IS FOR A SINGLE USE RELOADABLE CLIP APPLICATOR. THE OTHER RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552146 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551981 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED FIVE EVENTS INVOLVING 10 DEVICES. EACH EVENT INVOLVED ONE SINGLE USE DISTAL COVER AND ONE EVIS EXERA III DUODENOVIDEOSCOPE. THIS MDR IS FOR A SINGLE USE RELOADABLE CLIP APPLICATOR. THE OTHER RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK. PATIENT IDENTIFIER RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551959 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED FIVE EVENTS INVOLVING 10 DEVICES. EACH EVENT INVOLVED ONE SINGLE USE DISTAL COVER AND ONE EVIS EXERA III DUODENOVIDEOSCOPE. THIS MDR IS FOR A SINGLE USE RELOADABLE CLIP APPLICATOR. THE OTHER RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO (B)(6) - MODEL NUMBER: HX-810UR, LOT#: 2YK, PATIENT IDENTIFIER RELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551267 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS LINKED TO THE FOLLOWING PATIENT IDENTIFIERS:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550697 ↗
• MalfunctionAug 15, 2023Separation Failure; Separation Failure

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE RELOADABLE CLIP APPLICATOR HAD AN ISSUE. THE CUSTOMER SUCCESSFULLY PUT THE CLIP ON THE CLIP APPLICATOR, INSERTING THE DEVICE THROUGH WORKING CHANNEL, OPENING THE CLIP, BUT AT THE POINT OF CLOSING THE CLIP, THE CLIP DID NOT DETACH FROM CLIP APPLICATOR. THE CUSTOMER HAD TO PULL THE CLIP APPLICATOR, WITH THE CLIP ON, AWAY FROM THE BLEEDING POINT AND QUICKLY RESOLVE THE BLEEDING WITH BOSTON SCIENTIFIC RESOLUTION CLIP. THE ISSUE WAS OBSERVED DURING A THERAPEUTIC (HEMOSTASIS) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550541 ↗