Rotatable Clip Fixing Device HX-110QRRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170200205), received between Jul 18, 2019 and May 20, 2025 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC MARKING (EMR) FOR COLON SURGERY, FOR PERFORMING A MEASURE OF HEMOSTASIS, THE ROTATABLE CLIP SLIDER DEVICE (HX-110QR) WAS ABLE TO BE OPERATED. HOWEVER, THE CLIP (HX-610-135) DID NOT CLOSE AND THE BULLET WAS OPENED. THE CLIP (HX-610-135) COULD NOT BE REMOVED FROM THE ROTATABLE CLIP SLIDER (HX-110QR). IT WAS ATTEMPTED TO CONFIRM WHAT SPECIFIC AREA WAS GETTING CAUGHT AND COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS EVENT INCLUDES (2) REPORTS. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052765 ↗
• MalfunctionMay 15, 2025Separation Problem; Separation Problem

  NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031297 ↗
• InjuryJan 21, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THERE WAS NO FURTHER MEDICAL INTERVENTION OR TREATMENT PERFORMED WITH THE POTENTIAL FOREIGN BODY LEFT IN THE PATIENT'S LARGE INTESTINE. THE CUSTOMER CONFIRMED NO FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 21202958 ↗
• MalfunctionNov 25, 2024Material Too Rigid or Stiff; Activation Failure; Material Too Rigid or Stiff; Activation Failure

  IT WAS REPORTED, THE ROTATABLE CLIP FIXING DEVICE HAD A CLIP WAS DIFFICULT TO HIT. AND THE HANDLE BECAME QUITE STIFF PARTWAY THROUGH. THE ISSUE OCCURRED, DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776068 ↗
• MalfunctionOct 28, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE ROTATABLE CLIP FIXING DEVICE¿S CONTROL WIRE TIP BLACK COATING WAS PEELING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553490 ↗
• MalfunctionAug 14, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE ROTATABLE CLIP FIXING EXPERIENCED DIFFICULTY REMOVING THE CLIP GRIPPING THE MUCOSA FROM THE APPLICATOR, IT WAS EVENTUALLY REMOVED BY SHAKING IT. THIS ISSUE OCCURRED DURING A THERAPEUTIC COLON POLYPECTOMY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985894 ↗
• MalfunctionAug 8, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE ROTATABLE CLIP FIXING DEVICE EXHIBITED AN ISSUE WERE THE CLIP GRIPPING THE MUCOSA COULD NOT BE REMOVED FROM THE APPLICATOR. HOWEVER, IT WAS SUBSEQUENTLY REMOVED BY SHAKING IT. THE ISSUE WAS FOUND DURING A THERAPEUTIC COLON POLYPECTOMY PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS COMPLAINT IS RELATED TO (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943690 ↗
• MalfunctionJun 10, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE ROTATABLE CLIP FIXING DEVICE HAD PROBLEMS CAUSED BY IMPROPER REPROCESSING (FOREIGN MATTER). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499585 ↗
• MalfunctionApr 19, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE ROTATABLE CLIP FIXING DEVICE WAS SO HARD THAT THE CLIP'S BULLET COULD NOT BE REMOVED, THE CUSTOMER TOUCHED THE CLIP AND SOMEHOW MANAGED TO FORCE IT, AND THE CLIP'S BULLET CAME OFF BY ITSELF. THE CLIP THAT COULDN'T BE REMOVE WAS FORCIBLY REMOVED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE, AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149279 ↗
• MalfunctionApr 19, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THE ROTATABLE CLIP FIXING DEVICE, TIP DID NOT COME OFF PROPERLY, AND HAD TO FORCIBLY TEAR IT OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC HEMOSTASIS. THERE WAS NO REPORT OF DELAY, AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19147889 ↗
• InjuryFeb 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE "UNDERWATER ENDOSCOPIC MUCOSAL RESECTION WITH SUBMUCOSAL INJECTION AND MARKING' FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS TO ACHIEVE R0 RESECTION: A SINGLE-CENTER CASE SERIES." ABSTRACT OBJECTIVES: TO DESCRIBE AN ENDOSCOPIC TECHNIQUE NAMED ¿UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) WITH SUBMUCOSAL INJECTION AND MARKING (UEMR-SIM)¿ AND TO EVALUATE THE THERAPEUTIC CHARACTERISTICS OF SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS (SNADETS) < 20MM VIS-A-VIS CLASSICAL EMR (CEMR) AND UEMR TECHNIQUES. MATERIALS AND METHODS: THIS RETROSPECTIVE STUDY INCLUDED 103 CONSECUTIVE SNADET PATIENTS (103 LESIONS) WHO UNDERWENT CEMR, UEMR, OR UEMR-SIM. THE UEMR-SIM PROCEDURE INCLUDED (1) MARKING AND SUBMUCOSAL INJECTION, (2) FILLING OF THE DUODENAL LUMEN WITH 0.9% SALINE, (3) SNARING OF THE LESION, AND (4) ELECTROSURGICAL REMOVAL. THE PROCEDURAL OUTCOMES WERE COMPARED BETWEEN THE UEMR-SIM AND OTHER-PROCEDURE GROUPS. RESULTS: THE EN BLOC RESECTION RATE WAS SIGNIFICANTLY HIGHER IN THE UEMR-SIM GROUP (100%) THAN IN THE CEMR GROUP (76.8%) (P.0.015) BUT WAS NOT STATISTICALLY DIFFERENT BETWEEN THE UEMR-SIM AND UEMR GROUPS (88.0%) (P.0.236)

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18774964 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE OPERATING WIRE COATING OF THE ROTATABLE CLIP FIXING DEVICE HAD PEELED OFF AFTER STERILIZATION. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632505 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT A BLACK RUST LIKE SUBSTANCE WAS FOUND OVER A WIDE AREA IN THE LOWER PART OF THE ROTATABLE CLIP FIXING DEVICE. THE ISSUE WAS FOUND DURING PRE-USE INSPECTION. THE MOVEMENT OF THE SLIDER WAS AWKWARD, MOST LIKELY DUE TO THE RUST. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THE CLEANING, DISINFECTION, AND STERILIZATION WAS DONE ACCORDING TO THE INSTRUCTION MANUAL. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631639 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT SOMETHING LIKE BLACK POWDER ADHERED TO THE STERILIZATION PACK OF THE ROTATABLE CLIP FIXING DEVICE. THE ISSUE OCCURRED AFTER STERILIZATION DURING REPROCESSING. THE CLEANING, DISINFECTION AND STERILIZATION PROCESS WAS DONE ACCORDING TO THE INSTRUCTION FOR USE. THE DEVICE WAS NOT USED AFTER THE BLACK POWDER WAS DISCOVERED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629787 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE CLIP OF THE ROTATABLE CLIP FIXING DEVICE DID NOT COME OUT FROM THE TIP OF THE SHEATH WHEN TRYING TO INSERT IT INTO THE SCOPE AND PULL IT OUT. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WAS A STRONG SENSE OF RESISTANCE AND IT DID NOT COME OUT EVEN IF THE SLIDER WAS PUSHED OR PULLED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. AFTER THE PROCEDURE, THE DEVICE WAS CHECKED AND THE CLIP CAME OUT EVEN THOUGH THERE WAS SOME RESISTANCE. THE FREQUENCY OF USE WAS NOTED TO NOT BE HIGH AND THERE WAS A SCRAPE ON THE TIP. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629129 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE COATING ON THE OPERATION WIRE OF THE ROTATABLE CLIP FIXING DEVICE CAME OFF. THE ISSUE OCCURRED DURING REPROCESSING AFTER A THERAPEUTIC PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628979 ↗
• MalfunctionNov 6, 2023Mechanical Jam; Mechanical Jam

  IT IS UNKNOWN AT WHAT SECTION OF THE LARGE INTESTINE THE REPORTED ISSUE OCCURRED. ALTHOUGH THE CLIP WOULD NOT DETACH, IT WAS REMOVED BY "MOVING THE MAIN BODY OF THE CLIPPING DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18071033 ↗
• InjuryAug 31, 2023Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED TO OLYMPUS THE ROTATABLE CLIP FIXING DEVICE DID NOT CORRECTLY RELEASE A SINGLE-USE CLIP. WHILE USING THE SINGLE-USE CLIP FOR HEMOSTASIS BETWEEN THE DESCENDING COLON AND THE SIGMOID COLON, THE CLIP BECAME STUCK IN THE ROTATABLE CLIP FIXING DEVICE. IT WAS STATED THAT THE "CONNECTING ROD REMAINED ON THE MAIN BODY SIDE." THE USER HAD TO USE EMERGENCY INTERVENTION MEASURES TO REMOVE THE DEVICE FROM THE PATIENT. THE CLIP WAS CRUSHED WITH GRASPING FORCEPS SO IT COULD BE REMOVED THROUGH THE SCOPE CHANNEL. THIS CAUSED A 10-MINUTE EXTENSION OF THE PROCEDURE AS THE CLIP WAS REMOVED FROM THE PATIENT. THERE WAS NO ADDITIONAL IMPACT ON THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666087 ↗
• MalfunctionMay 18, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, WHEN THE USER MOVED THE OPERATING HANDLE OF THE ROTATABLE CLIP FIXING DEVICE. BLACK SAND LIKE FOREIGN MATERIAL CAME OUT OF THE COIL SHEATH FROM THE TIP OF THE DEVICE. THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE WAS WASHED AGAIN, BUT THE SAME ISSUE OCCURRED AGAIN. AFTER THE FOREIGN MATERIAL WAS FOUND, THE DEVICE WAS NOT USED. AND THERE WERE NO REPORTS OF ANY HEALTH DAMAGE OR PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952890 ↗
• MalfunctionApr 28, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE NURSE AT THE USER FACILITY REPORTED TO OLYMPUS THAT DURING REPROCESSING AFTER THE PROCEDURE, THE ROTATABLE CLIP FIXING DEVICE WAS WASHED BY HAND USING ¿ENDOFRESH¿ AND AFTER APPLYING ¿STIN MILK¿, THE DEVICE WAS HUNG FOR DRYING AND BLOOD WAS FOUND DRIPPING FROM THE COIL SHEATH OF THE DEVICE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED AS A RESULT OF THE DEFECT. IT WAS REPORTED THE REPROCESSING OF THE DEVICE DID NOT INVOLVE ULTRASONIC CLEANING BUT WAS AUTOCLAVE STERILIZED AFTER WASHING BY HAND. THIS REPORT WAS SUBMITTED TO THE REPORT OF CAPTURE THE POTENTIAL FOR INSUFFICIENT CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833461 ↗
• MalfunctionJan 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC CLIP HEMOSTASIS PROCEDURE, THE ROTATABLE CLIP FIXING DEVICE RELEASE FAILED AFTER CLIPPING. THE CLIP DID NOT COME OFF EASILY FROM THE APPLICATOR BUT WAS ABLE TO COME OFF WHILE THE OPERATOR WAS MOVING THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16199777 ↗
• MalfunctionAug 2, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC HEMOSTASIS PROCEDURE, THE CLIP WAS NOT RELEASE FROM THE DEVICE, ALTHOUGH THE DEVICE SLIDER WAS PULLED AND CLICKED. THE DEVICE WAS ABLE TO CLIP BUT NOT RELEASE THE CLIP. THE DEVICE HAD TO BE FORCIBLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS NOT INSPECTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146326 ↗
• MalfunctionApr 29, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT RUST WAS ADHERED TO THE OPERATION WIRE OF THE SUBJECT DEVICE AND MOVEMENT OF THE SLIDER WAS DIFFICULT. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE (FOREIGN MATERIAL ON THE OPERATION WIRE) REPORTED BY THE CUSTOMER. THE REPORTED ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. THE DEVICE HAD BEEN REPROCESSED BY AUTOCLAVE STERILIZATION. THERE WAS NO REPORT OF PATIENT OR USER HARM DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14252789 ↗
• MalfunctionApr 29, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT RUST WAS ADHERED TO THE OPERATION WIRE OF THE SUBJECT DEVICE AND MOVEMENT OF THE SLIDER WAS DIFFICULT. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE (FOREIGN MATERIAL ON THE OPERATION WIRE) REPORTED BY THE CUSTOMER. THE REPORTED ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. THE DEVICE HAD BEEN REPROCESSED BY AUTOCLAVE STERILIZATION. THERE WAS NO REPORT OF PATIENT OR USER HARM DUE TO THE EVENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14252140 ↗
• InjuryNov 10, 2019Difficult to Remove; Difficult to Remove

  WE RECEIVED THE FOLLOWING REPORT. DURING A PROCEDURE, THE SUBJECT DEVICE (CLIP FIXING DEVICE) WAS USED FOR HEMOSTASIS. THE CLIP USED IN COMBINATION WITH THE SUBJECT DEVICE COULD NOT BE RELEASED AFTER CLIPPING PATIENT'S TISSUE. THE USER TRIED TO REMOVE THE SUBJECT DEVICE FROM THE PATIENT. THE SUBJECT DEVICE WAS REMOVED FROM THE CLIP. THE INTENDED HEMOSTASIS COULD NOT BE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ON OCT 31, 2019, THE FOLLOWING INFORMATION WAS PROVIDED. THE SUBJECT DEVICE WAS REMOVED TOGETHER WITH THE CLIP THAT GRABBED THE TISSUE. AS A RESULT, THE PATIENT BLED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER CLIP IN COMBINATION WITH THE SUBJECT DEVICE.

  Patient problems: Tissue Damage

  MAUDE report 9302838 ↗