Single Use Rotatable Clip Fixing Device HX-201UR-135LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170353161), received between Dec 30, 2020 and Jan 4, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Misfire” (4 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. Feb 23, 2023Class IIOpen, Classified

   There have been complaints that the clip did not come out of the tube sheath during the procedure.

   Z-1418-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2021Misfire; Misfire

  IT IS REPORTED IN USER FACILITY MEDWATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (THIS REPORT). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECAU

  Patient problems: Blood Loss

  MAUDE report 11107359 ↗
• InjuryDec 30, 2020Misfire; Misfire

  IT IS REPORTED IN USER FACILITY MED WATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND THIS REPORT). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MOR

  Patient problems: Blood Loss

  MAUDE report 11094889 ↗
• InjuryDec 30, 2020Firing Problem

  IT IS REPORTED IN USER FACILITY MED WATCH (B)(4) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND THIS REPORT). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE C

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 11094860 ↗
• InjuryDec 30, 2020Misfire; Misfire

  IT IS REPORTED IN USER FACILITY MED WATCH (B)(4) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (THIS REPORT). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECAUSE

  Patient problems: Blood Loss

  MAUDE report 11094827 ↗
• InjuryDec 30, 2020Misfire; Misfire

  IT IS REPORTED IN USER FACILITY MED WATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (THIS REPORT, AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECA

  Patient problems: Blood Loss

  MAUDE report 11094823 ↗
• InjuryDec 30, 2020Firing Problem

  IT IS REPORTED IN USER FACILITY MED WATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (THIS REPORT, AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 11094820 ↗
• InjuryDec 30, 2020Failure to Fire; Device Dislodged or Dislocated; Migration

  IT IS REPORTED IN USER FACILITY MEDWATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (THIS REPORT). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECAU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 11094778 ↗
• InjuryDec 30, 2020Device Dislodged or Dislocated; Migration; Firing Problem

  IT IS REPORTED IN USER FACILITY MED WATCH ((B)(4)) AND FOLLOW-UP INFORMATION PROVIDED BY THE CUSTOMER, DURING AN EMERGENT REPAIR OF A GASTROINTESTINAL (GI) BLEED, A SINGLE USE ROTATABLE CLIP FIXING DEVICE FAILED TO DETACH WHEN FIRED (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6)). THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. A SECOND CLIP WAS DEPLOYED, AND IT ALSO FAILED TO DETACH APPROPRIATELY (THIS REPORT). TWO OTHER CLIPS WERE TEST FIRED INTO A BLANKET AND THOSE FAILED TO DETACH APPROPRIATELY (REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6), AND CASE WITH PATIENT IDENTIFIER (B)(6)). ADDITIONAL DETAILS AND SERIES OF EVENTS AS FOLLOWS: AT THE BEGINNING OF THE PROCEDURE, IRRIGATION WAS PERFORMED, REMOVING A CLOT. THIS REVEALED A SLOW PULSATING BLEED. ATTEMPTED TO CONTROL BLEEDING WITH CLIP- CLIPPING DEVICE MALFUNCTIONED. ONE CLIP FIRED BUT DID NOT DETACH FROM THE DEVICE. THIS CAUSED THE TISSUE TO TEAR AND INCREASED BLEEDING TO OCCUR. THE SURGEON ATTEMPTED TO PLACE ANOTHER CLIP, BUT THE SAME THING HAPPENED. AT THAT POINT THE PATIENT STARTED TO BLEED BRISKLY. A SECOND SURGEON WAS CALLED IN TO ASSIST. THE SECOND SURGEON DID NOT ATTEMPT TO PLACE ANY MORE CLIPS BECA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 11094772 ↗