Single Use Rotatable Clip Fixing Device HX-201UR-135 (UDI 04953170193026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170193026), received between Aug 21, 2018 and Feb 2, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED TO OLYMPUS EZCLIP DIDN¿T GET LOOSE AFTER ATTACHING TO THE COLON CLOSING THE FORCEPS (WERE AT THE HIGHEST POINT IN THE COLON). THE USER HAD TO OPEN AND CLOSE SEVERAL TIMES. THE INTENDED PROCEDURE WAS COLONOSCOPY POLYP REMOVAL AND WAS COMPLETED WITH ANOTHER EZCLIP. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630750 ↗
• InjuryOct 20, 2023Break; Unintended System Motion; Detachment of Device or Device Component; Break; Unintended System Motion; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE, AND IN TURN, THE PATIENT'S ANESTHESIA, WERE EXTENDED FOR AN UNKNOWN DURATION DUE TO THE NEED TO USE ANOTHER DEVICE TO SOLVE THE ISSUE. THE CUSTOMER ALSO NOTED THAT THERE WAS "BREAKAGE AND/OR FALL OF ANY FRAGMENT IN ANY CAVITY OF THE PATIENT" DURING THE USE OF THE DEVICE, WHICH WAS OBSERVED AT THE INITIAL POINT OF THE PROCEDURE. THERE WERE NO REPORTS OF ANY UNEXPECTED BLEEDING DURING THE PROCEDURE AND NO NEED FOR LONGER HOSPITALIZATION OR SURGERY DUE TO AVAILABILITY OF OTHER TYPES OF ENDOCLIPS WITH MORE EFFICIENT FUNCTIONING AS WELL AS OTHER TECHNIQUES ENDOSCOPISTS USE TO AVOID THIS OUTCOME. THE CUSTOMER INDICATED THAT THE PROCEDURE WAS NOT COMPLETED. HOWEVER, AN OLYMPUS REPRESENTATIVE REPORTED THAT THE PROCEDURE HAD TO BE COMPLETED WITH ANOTHER DEVICE. THERE WAS NO FURTHER PATIENT IMPACT REPORTED. AN OLYMPUS PRODUCT SPECIALIST ALSO COMMENTED THAT THE CUSTOMER WAS NOT USED TO THIS PRODUCT AND DID NOT REQUEST TRAINING. CONSEQUENTLY, THE PHYSICIAN HAS BEEN CONTACTED FOR TRAINING. ADDITIONAL INFORMATION HAS BEEN REQUESTED CLARIFYING THE EVENT DETAILS; HOWEVER, NO FURTHER INFORMATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981123 ↗
• MalfunctionAug 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC COLONOSCOPY PROCEDURE, A SMALL PIECE OF METAL BROKE OFF FROM A THIRD CLIP AND FELL INTO THE PATIENT¿S COLON. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE FIRST TWO CLIPS SUCCESSFULLY; HOWEVER, THIS CLIP REQUIRED MULTIPLE ATTEMPTS. THE PATIENT'S COLON FLUSHED AND THE DEVICE FRAGMENT WAS THEN SUCTION OUT. THERE WAS NO ADDITIONAL BLEEDING OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7803927 ↗