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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170353147), received between Oct 28, 2022 and Nov 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2022Break; Break

  THE CUSTOMER REPORTED, DURING AN (B)(6) 2022 THERAPEUTIC EMERGENCY PROCEDURE TO CONTROL BLEEDING, FOR A BLEEDING BULBAR ULCER, THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING WITH THE OLYMPUS CLIPS BUT TWO CLIPS FAILED TWICE AND DID NOT COME OUTSIDE OF THE SHEATH. THE SURGEON CONTROLLED THE ACTIVE BLEEDING BY INJECTING ADRENALINE AND SCLEROSANT (LAUROMACROGOL). THE PATIENT WAS TRANSFERRED TO A LEVEL 2 ENDOSCOPY FACILITY WITH EMERGENCY SERVICE AS A PRECAUTIONARY MEASURE TO MAKE SURE THE PATIENT RECEIVED THE MOST APPROPRIATE SERVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO DAMAGES IDENTIFIED. THE CUSTOMER RETURNED 2 CLIPS AND CONFIRMED THE 2 CLIPS FAILED TO DEPLOY OUTSIDE THE SHEATH DURING THIS SAME PROCEDURE. THIS EVENT INCLUDES 2 REPORTS: (B)(6): CLIP 1. (B)(6): CLIP 2. THIS REPORT IS 2 OF 2 FOR (B)(6): CLIP 2.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15828388 ↗
• InjuryOct 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED, DURING AN (B)(6) 2022 THERAPEUTIC EMERGENCY PROCEDURE TO CONTROL BLEEDING FOR A BLEEDING BULBAR ULCER, THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING WITH THE SUBJECT DEVICE BUT IT FAILED. THE SURGEON CONTROLLED THE ACTIVE BLEEDING BY INJECTING ADRENALINE AND SCLEROSANT (LAUROMACROGOL). THE PATIENT WAS TRANSFERRED TO A LEVEL 2 ENDOSCOPY FACILITY WITH EMERGENCY SERVICE AS A PRECAUTIONARY MEASURE TO MAKE SURE THE PATIENT RECEIVED THE MOST APPROPRIATE SERVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO DAMAGES IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15690956 ↗