Long ClipRecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 4 models of Long Clip by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2019 and Sep 18, 2025 — classified as 24 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Long Clip problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Detachment of Device or Device Component10
- Physical Resistance/Sticking4
- Mechanical Problem2
- Separation Failure2
- Break1
- Difficult to Remove1
- Failure to Clean Adequately1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Hemorrhage/Blood Loss/Bleeding13
- Unspecified Respiratory Problem4
- Perforation3
- Foreign Body In Patient1
- Hematemesis1
- No Consequences Or Impact To Patient1
- Obstruction/Occlusion1
Long Clip models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Long Clip HX-610-090LHemostatic Metal Clip For The Gi Tract22 reports
- Long Clip HX-610-090LHemostatic metal clip for the GI tract8 reports
- Long Clip HX-610-135LHemostatic Metal Clip For The Gi Tract5 reports
- Long Clip HX-610-135LHemostatic metal clip for the GI tract5 reports
Recent Long Clip adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022244 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022236 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022226 ↗InjuryMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22022225 ↗InjuryNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20790599 ↗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 ↗MalfunctionApr 5, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE LONG CLIP THAT GRIPS THE PATIENT MUCOUS MEMBRANE COULD NOT BE DETACHED FROM THE APPLICATOR. THE ISSUE OCCURRED DURING A PERORAL ENDOSCOPIC MYOTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055840 ↗InjuryDec 15, 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 "CAN UNDERWATER ENDOSCOPIC MUCOSAL RESECTION BE AN ALTERNATIVE TO CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS?" LITERATURE SUMMARY OBJECTIVES: UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) IS A SIMPLER PROCEDURE FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS (SYNDET) THAN CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR). THIS STUDY AIMED TO EVALUATE WHETHER CEMR CAN BE SUBSTITUTED BY UEMR FOR SNADET IN TERMS OF EFFECTIVENESS, SAFETY, AND LEARNING CURVE. METHODS: A TOTAL OF 157 CONSECUTIVE PATIENTS WITH 203 SNADETS <20 MM IN DIAMETER, INCLUDING 107 LESIONS RESECTED BY CEMR AND 96 LESIONS RESECTED BY UEMR, BETWEEN JANUARY 2019 AND MAY 2023, WERE RETROSPECTIVELY RECRUITED. THE TREATMENT OUTCOMES WERE COMPARED BETWEEN THE CEMR AND UEMR GROUPS. THE RISK FACTORS FOR INCOMPLETE RESECTION BY UEMR WERE ANALYZED USING UNIVARIATE AND MULTIVARIATE ANALYSES. LESIONS IN THE UEMR GROUP WERE DIVIDED CHRONOLOGICALLY INTO FIVE PERIODS; THEREAFTER, THE EN BLOC RESECTION RATE AND PROCEDURE TIME WERE COMPARED. RESULTS: NO SIGNIFICANT DIFFERENCES EXISTED BETWEEN THE CEMR AN
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18335889 ↗InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED A LITERATURE ARTICLE TITLED "EVALUATION OF A NEW METHOD, "NON-INJECTION RESECTION USING BIPOLAR SOFT COAGULATION MODE (NIRBS)", FOR COLONIC ADENOMATOUS LESIONS." THIS RETROSPECTIVE STUDY DEVELOPED A NEW ¿NON-INJECTION RESECTION USING BIPOLAR SOFT COAGULATION MODE (NIRBS)¿ METHOD, ADAPTED FOR COLORECTAL LESIONS. IN ADDITION, WE EVALUATED THE EFFECTIVENESS OF THIS METHOD. WE PERFORMED NIRBS THROUGHOUT A 12-MONTH PERIOD FOR ALL COLORECTAL LESIONS WHICH SNARE RESECTION WAS ACCEPTABLE WITHOUT CANCEROUS LESIONS INFILTRATING DEEPER THAN THE SUBMUCOSAL LAYER. A TOTAL OF 746 LESIONS WERE RESECTED FROM 375 PATIENTS. THE MAJOR PATHOLOGICAL BREAKDOWNS WERE AS FOLLOWS: 64.3% (480/746) WERE ADENOMAS, AND 5.0% (37/746) WERE INTRAEPITHELIAL ADENOCARCINOMAS (TIS LESIONS). NO RESIDUALS WERE OBSERVED IN ANY 37 TIS LESIONS (MEAN SIZE, 15.3 MM). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. THIS STUDY ONLY EVALUATED MAJOR ADVERSE EVENTS SUCH AS BLEEDING DURING THE PROCEDURE, DELAYED BLEEDING, AND PERFORATION. ¿BLEEDING DURING THE PROCEDURE¿¿PROFUSE BLEEDING THAT OCCURRED FROM THE RESECTED PORTION IMMEDIATELY AFTER RESECTION. ¿DELAYED BLEEDING¿: A LARGE AMOUNT OF FRESH BLEEDING OR BLOODY S
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18318645 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REQUESTED CLARIFICATION OF THE REPORTED EVENT AND RECEIVED THE FOLLOWING TIMELINE FROM THE CUSTOMER: 1. A CLIP WAS INSERTED INTO THE RELEVANT SCOPE DURING THE PREVIOUS PROCEDURE. (THE CLIP WAS NOT USED IN THE PREVIOUS PROCEDURE). 2. THE CLIP AND CONNECTING ROD WERE NOT ATTACHED WHEN THE CLIP WAS REMOVED FROM THE SCOPE DURING THE PREVIOUS PROCEDURE. 3. WHEN THE SCOPE WAS REPROCESSED BY CLEANING, THE CLIP AND CONNECTING ROD WERE NOT FOUND. 4. THE CONNECTING ROD FELL OFF WHEN THE SCOPE WAS USED DURING THE SUBSEQUENT PROCEDURE. THE CLIP WAS MISSING. FURTHERMORE, ALTHOUGH THE CLIP HAD FALLEN OFF AND WAS MISSING, THERE WAS NO PLAN TO RETRIEVE IT FROM THE PATIENT¿S BODY. THE CLIP IS NOT COLLECTED EVEN WHEN IT IS USED INTENTIONALLY, AS IT IS BELIEVED TO BE EJECTED NATURALLY FROM THE PATIENT¿S BODY VIA STOOL. BOTH PATIENTS (IN PREVIOUS AND SUBSEQUENT PROCEDURE) WERE REPORTEDLY IN ¿MEDICAL CHECKUP¿ AND NOT HOSPITALIZED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 17908942 ↗MalfunctionAug 29, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THE LONG CLIP WAS SUCCESSFULLY ATTACHED TO THE SINGLE USE RELOADABLE CLIP APPLICATOR, PASSED THROUGH THE WORKING CHANNEL, AND OPENED DURING HEMOSTASIS IN A THERAPEUTIC PROCEDURE. WHEN TRYING TO CLOSE THE CLIP, THE CLIP DID NOT DETACH FROM THE CLIP APPLICATOR. THE INSIDE WIRE OF THE CLIP APPLICATOR BROKE FROM THE HANDLE, GOT LOOSE AND DID NOT RELEASE THE CLIP. THE PROBLEM WAS NOTED TO BE THE CLIP. THERE WAS A SMALL DELAY TO SWITCH TO A CLIP FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE AND SOLVE SOME BLEEDING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. RELATED PATIENT IDENTIFIERS ARE (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17640002 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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