Rotatable Clip Fixing Device HX-110LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170200182), received between Mar 30, 2022 and Oct 7, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

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.

• MalfunctionOct 7, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE ROTATABLE CLIP FIXING DEVICE GRIPPED THE MUCOUS MEMBRANE AND COULD NOT BE RELEASED. THE DOCTOR REMOVED THE CLIP FROM THE APPLICATOR BY HAND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391179 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED: "INDICATIONS FOR DENTAL FLOSS CLIP TRACTION DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BY LESS-EXPERIENCED ENDOSCOPISTS." THIS RETROSPECTIVE STUDY INVESTIGATED THE INDICATIONS OF DENTAL FLOSS CLIP (DFC) IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED BY LESS-EXPERIENCED ENDOSCOPISTS FOR EARLY GASTRIC CANCER. A TOTAL OF 812 PATIENTS WERE INCLUDED. THE PROCEDURE TIME IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP (95±46 VS. 75±31, P<0.01). THE PROCEDURE TIME FOR LESIONS LOCATED IN THE GREATER CURVATURE OF THE UPPER OR MIDDLE STOMACH AND LESIONS >20 MM LOCATED IN THE LESSER CURVATURE SIDE OF THE STOMACH IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING - 30 PATIENTS, PERFORATION - 10 PATIENTS. DELAYED BLEEDING WAS DEFINED AS CLINICAL BLEEDING AFTER ESD THAT REQUIRED BLOOD TRANSFUSION OR ENDOSCOPIC OR SURGICAL INTERVENTION. PERFORATION WAS DIAGNOSED WHEN MESENTERIC FAT OR INTRA-ABDOMINAL SPACE WAS OBSERVED DURING THE PROCEDURE OR WHEN FREE AIR WAS IDENTIFIED ON SIMPLE CHEST AND ABDOMINAL RADIOGRAPHS AFTER ESD. RELATED P

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18515225 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMS THERE WERE NO OLYMPUS DEVICE MALFUNCTION AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury

  MAUDE report 16938246 ↗
• MalfunctionMay 12, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE GASTROINTESTINAL VIDEOSCOPE WHEN USED ALONG WITH HX-110LR-ROTATABLE CLIP FIXING DEVICE, A BLACKISH LIQUID WAS SEEN EXITING FROM THE AUXILIARY WATER CHANNEL. THE ISSUE WAS FOUND DURING THE MIDDLE OF THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE WHICH WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THE FACILITY HAS REQUESTED AN INVESTIGATION OF THE COMPOSITION OF THE LIQUID. REPORTEDLY, SIMILAR EVENT OCCURRED DURING MULTIPLE PROCEDURES. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER: COMPLAINT (B)(6); GIF-XZ1200; GASTROINTESTINAL VIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924665 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORPORATION RECEIVED A LITERATURE TITLED "FEASIBILITY STUDY OF PARTIAL SUBMUCOSAL INJECTION TECHNIQUE COMBINING UNDERWATER EMR FOR SUPERFICIAL DUODENAL EPITHELIAL TUMORS." LITERATURE SUMMARY: THIS PROSPECTIVE OBSERVATIONAL STUDY EXPLAINED FEASIBILITY AND SAFETY OF PARTIAL SUBMUCOSAL INJECTION COMBINING UNDER WATER ENDOSCOPIC MUCOSAL RESECTION (PI-UEMR) FOR SUPERFICIAL DUODENAL TUMOR (SDET). A TOTAL OF 30 PATIENTS WERE INVOLVED WHICH UNDERWENT PI-UEMR USING GIF-Q260J OR GIF-H290T- GASTROSCOPE, ENDOSCOPIC SNARE, ENDOSCOPIC CLIP AND MANY OTHER DEVICES. EN BLOC RESECTION RATE WAS 97%. R0 RESECTION RATE WAS 83%. MEAN TOTAL PROCEDURE TIME WAS 17±12 MIN. COMPLICATIONS LIKE INTRAOPERATIVE BLEEDING WAS OBSERVED IN ONE CASE AND DURING HISTOLOGICAL FINDINGS 29 CASES OF TUBULAR ADENOMA AND ONE CASE OF DUODENITIS WERE OBSERVED. THE STUDY CONCLUDED THAT PI-UEMR MIGHT BE VERY USEFUL AND SAFE TECHNIQUE OF ENDOSCOPIC RESECTION FOR SDET INCLUDING RELATIVELY LARGE LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE BLEEDING (1) HISTOLOGICAL FINDINGS: TUBULAR ADENOMA 29), DUODENITIS (1) SINCE THE LITERATURE DESCRIBED "SNAREMASTER (10, 15, OR 20 MM)", WE SELECTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14580422 ↗
• MalfunctionMay 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THROUGH THE OLYMPUS CALL CENTER THAT TREATMENT TOOLS WERE NOT PROPERLY REPROCESSED. THE ITEMS WERE GAS STERILIZED AT THE FACILITY'S AUTOCLAVE SETTING OF 136 DEGREES FOR TEN MINUTES. THE CUSTOMER WAS INFORMED OF THE POTENTIAL FOR CROSS-CONTAMINATION IF AN UNSTERILIZED TREATMENT TOOL IS USED THROUGH A HIGH-LEVEL DISINFECTED ENDOSCOPE. NO FURTHER CUSTOMER CONTACT INFORMATION WAS PROVIDED, THEREFORE, ADDITIONAL INFORMATION REGARDING THIS EVENT CANNOT BE OBTAINED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428541 ↗
• MalfunctionApr 11, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE PRE-USE INSPECTION OF THE HX-110LR, THE OPERATION WIRE OF THE CLIP DEVICE COULD NOT BE PROJECTED (STUCK), WHEN THE INSIDE OF THE COIL SHEATH WAS CHECKED, IT WAS FOUND THAT SOMETHING LIKE METAL OR PLASTIC WAS CLOGGED INSIDE THE COIL SHEATH. NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14076185 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF POST-POLYPECTOMY BLEEDING EVENTS BETWEEN COLD SNARE POLYPECTOMY AND HOT SNARE POLYPECTOMY FOR SMALL COLORECTAL LESIONS: A LARGE-SCALE PROPENSITY SCORE-MATCHED ANALYSIS," PATIENTS EXPERIENCED POST-POLYPECTOMY BLEEDING EVENTS AFTER PROCEDURES USING SNAREMASTER (SD-210L-10) OR SNAREMASTER PLUS (SD-400U-10). COLD SNARE POLYPECTOMY (CSP) GROUP: SEVEN PATIENT EXPERIENCED POST-POLYPECTOMY BLEEDING. ALL PATIENTS IN THE CSP GROUP WERE TREATED ENDOSCOPICALLY WITH NO TRANSFUSIONS NEEDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4/7- (SD-210L-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 6/7- (SD-400U-10). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 7/7- (SD-400U-10). HOT SNARE POLYPECTOMY (HSP) GROUP. CASE WITH PATIENT IDENTIFIER (B)(6) -REPORTS THE HSP GROUP PATIENTS EXPERIENCING PPB AFTER PROCEDURES USING: SD-210L-10. CASE WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13953592 ↗