Long Clip HX-610-090L (REF N6012730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170415159), received between Sep 29, 2022 and Sep 18, 2025 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CLIP WAS REMOVED FROM THE SHEATH FOR USE ON A LESION INSIDE THE PATIENT¿S BODY, BUT IT DETACHED IMMEDIATELY AND BECAME UNUSABLE. THE DETACHED CLIP WAS RETRIEVED FROM THE PATIENT¿S BODY AND DISPOSED OF BY THE HOSPITAL. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089685 ↗
• MalfunctionOct 7, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THE LONG CLIP THAT GRIPS THE MUCOUS MEMBRANE HAD NOT BEEN ABLE TO BE DETACHED AND IT WAS REMOVED BY HAND BY THE DOCTOR. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20388156 ↗
• MalfunctionOct 2, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE LONG CLIP COULD NOT BE FIRED OR WITH DIFFICULTIES. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354401 ↗
• InjurySep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE CLIP FELL OFF INSIDE THE PATIENT'S BODY AND WAS RETRIEVED. IT IS UNKNOWN, WHERE IT FELL OFF, BUT IT WAS NOT INSIDE THE ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED, AFTER REPLACING IT WITH A SIMILAR DEVICE. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158510 ↗
• MalfunctionAug 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED A HEMOSTASIS CLIP WAS SUCTIONED WITHIN THE PATIENT¿S STOMACH AND CAUSED SUCTION ISSUES DURING A DIAGNOSTIC ENDOSCOPIC PROCEDURE AND THE CUSTOMER SUSPECTS THE CLIP MAY HAVE REMAINED WITHIN THE GASTROINTESTINAL VIDEOSCOPE AFTER A PREVIOUS PROCEDURE AND IT WAS NOT REPROCESSED CORRECTLY. THE CLIP WAS SUCTIONED AND REMOVED DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061166 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "TECHNICAL OUTCOMES AND POSTPROCEDURAL COURSES OF MUCOSAL INCISION-ASSISTED BIOPSY FOR POSSIBLE GASTRIC GASTROINTESTINAL STROMAL TUMORS: A SERIES OF 48 CASES (WITH VIDEO)." MUCOSAL INCISION-ASSISTED BIOPSY (MIAB) HAS BEEN INTRODUCED AS AN ALTERNATIVE TO ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION FOR TISSUE SAMPLING OF SUBEPITHELIAL LESIONS. HOWEVER, THERE HAVE BEEN FEW REPORTS ON MIAB, AND THE EVIDENCE IS LACKING, PARTICULARLY IN SMALL LESIONS. IN THIS CASE SERIES, WE INVESTIGATED THE TECHNICAL OUTCOMES AND POSTPROCEDURAL INFLUENCES OF MIAB FOR GASTRIC SUBEPITHELIAL LESIONS 10 MM OR GREATER IN SIZE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: POSTOPERATIVE BLEEDING (N=1). NO INTRAOPERATIVE ADVERSE EVENTS OCCURRED, WHEREAS ONE PATIENT WITH SUBEPITHELIAL LESION GREATER THAN 20MM EXPERIENCED HAEMATEMESIS THE DAY AFTER MIAB. IN THIS CASE, NO BLEEDING WAS FOUND ON EMERGENCY ENDOSCOPY, AND THE PATIENT HAD NO SYMPTOMS THEREAFTER WITHOUT TRANSFUSION OR HEMOSTATIC TREATMENT. THIS EVENT REQUIRES 4 REPORTS. THE PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : GIF-Q260J, (B)(6) : D-201-11804, (B)(6) : FD-410LR, (B)(6) : HX-6

  Patient problems: Hematemesis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17450076 ↗
• MalfunctionMar 2, 2023Mechanical Jam; Mechanical Jam

  ADDENDUM MAR 7, 2023: THE EVENT OCCURRED DURING HEMOSTASIS. THERE WAS NO TISSUE INJURY DUE TO THE FORCIBLE REMOVAL OF THE CLIP DEVICE. THERE IS NO INFORMATION IF THE FORCIBLE REMOVAL OF THE CLIP DEVICE LED TO ANY BLEEDING. THERE WAS NO DAMAGE TO THE CLIP FIXING DEVICE DUE TO THE FORCIBLE REMOVAL OF THE CLIP DEVICE. THERE WAS ALMOST NO DELAY IN THE COMPLETION OF THE PROCEDURE. IT IS NOT KNOWN IF THE PATIENT NEEDED MORE ANESTHESIA. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ANOMALIES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466721 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION (EMR) FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS MAY REDUCE PROCEDURE TIME COMPARED WITH UNDERWATER EMR (WITH VIDEO)". LITERATURE SUMMARY: THIS RETROSPECTIVE COHORT STUDY WAS AIMED TO EVALUATE THE ENDOSCOPIC OUTCOMES OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) AND GEL IMMERSION EMR (GIEMR). TOTAL 23 PATIENTS WERE INCLUDED IN THIS STUDY. GIEMR SIGNIFICANTLY REDUCED THE PROCEDURE TIME COMPARED WITH UEMR. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE UEMR AND GIEMR GROUPS FOR EN BLOC RESECTION RATE AND R0 RESECTION RATE. THERE WAS ONE CASE OF INTRAOPERATIVE BLEEDING IN THE GIEMR GROUP AND ONE IN THE UEMR GROUP; BOTH OF WHICH WERE CONTROLLED WITH ENDOSCOPIC CLIPS. NO SERIOUS COMPLICATIONS WERE OBSERVED IN EITHER GROUP. THIS STUDY CONCLUDED THAT GIEMR WAS SAFE AND HAD GOOD THERAPEUTIC RESULTS FOR SNADETS AND SHOWED THE POTENTIAL TO ACCELERATE THE PROCEDURE TIME COMPARED WITH UEMR. THIS METHOD MAY BE PARTICULARLY USEFUL IN AREAS WHERE IMMERSION IN WATER IS DIFFICULT. INTRAOPERATIVE BLEEDING WAS DEFINED AS BLEEDING DURING OR IMMEDIATELY AFTER ENDOSCOPIC RESECTION. TYPE OF ADVE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15501597 ↗