Clip HX-610-135 (REF N6012430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170415128), received between Apr 12, 2022 and Aug 12, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE CLIP GRIPPING THE MUCOSA COULD NOT BE REMOVED DURING THE THERAPEUTIC COLON POLYPECTOMY PROCEDURE. IT WAS EVENTUALLY REMOVED BY SHAKING IT AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967638 ↗
• InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHEN THEY WERE TRYING TO STOP THE BLEEDING INSIDE THE PATIENT'S BODY, THE CLIP WAS NOT ABLE TO CLIP AND FELL INSIDE THE PATIENT'S BODY. THE FALLEN PART HAS BEEN RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HEALTH RISK TO THE PATIENT. IT WAS LATER REPORTED THREE CLIPS COULD NOT BE CLIPPED AND FELL INTO THE BODY. THE CLAWS WERE ALREADY CLOSED WHEN THEY WERE EJECTED FROM THE ROTATING CLIP DEVICE AND THE CONNECTING ROD CAME OFF THE HOOK AND FELL INTO THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649405 ↗
• InjuryApr 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, WHEN THE CLIP WAS USED IN COMBINATION WITH THE ROTATABLE CLIP FIXING DEVICE DURING A POLYPECTOMY, THE CLIP DID NOT COME OFF THE SHEATH AND WAS PULLED WHILE GRASPING THE MUCOUS MEMBRANE, RESULTING IN HEAVY BLEEDING. THE PHYSICIAN MANUALLY SUTURED THE RECTUM, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19088985 ↗
• MalfunctionJun 2, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE CUSTOMER REPORTED THAT, DURING A PROCEDURE, THE CONNECTING ROD DID NOT COME OFF THE CLIP AS EXPECTED. THE SCOPE WAS USED TO PUSH THE COIL SHEATH FORWARD AGAINST THE MUCOUS MEMBRANE TO REMOVE THE CONNECTING ROD FROM THE CLIP AND THE PROCEDURE WAS COMPLETED. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577982 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿EFFECTIVENESS OF COUNTER TRACTION USING A CLIP WITH A LOOPED THREAD FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: HX-610-135. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: KD-6555Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: CONVENTIONAL ESD (CESD)- GROUP (N-42) DEVICE: KD-6555Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: LOOPED THREAD (LT) GROUP (N-46)DEVICE: KD-6555Q. STUDY AIM: THE PRESENT STUDY WAS DESIGNED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A NOVEL TRACTION METHOD. METHOD: IN JUNE 2018, WE INTRODUCED A COUNTER TRACTION METHOD USING A CLIP WITH A LT. WE TREATED 120 CONSECUTIVE COLORECTAL LESIONS IN 119 PATIENTS USING ESD BEFORE AND AFTER THE INTRODUCTION OF THIS TRACTION METHOD AT THE YODOGAWA CHRISTIAN HOSPITAL BETWEEN JANUARY 2017 AND APRIL 2019. ESD WAS INDICATED FOR LESIONS SIZED > 20 MM OR FOR THOSE SIZED < 20 MM THAT WERE EXPECTED TO HAVE FIBROSIS AND WERE DEEMED DIFFICULT TO RESECT EN BLOC WITH TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14089641 ↗