Long Clip HX-610-135L (REF N2303930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170209154), received between Aug 19, 2021 and Dec 13, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionAug 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, WHEN THE LONG CLIP WAS ACTIVATED, THE CLIP STUCK TO THE APPLICATOR WHEN SHOOTING. IT DID NOT STICK TO THE MUCOSA. TWO (2) LONG CLIPS MALFUNCTIONED IN THE SAME MANNER DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO REPORTED PATIENT HARM. THERE WERE TWO (2) OCCURRENCES AT THE FACILITY ON THE SAME DAY WITH FOUR (4) DIFFERENT LONG CLIPS. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341420 ↗
• MalfunctionAug 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, WHEN THE LONG CLIP WAS ACTIVATED, THE CLIP STUCK TO THE APPLICATOR WHEN SHOOTING. IT DID NOT STICK TO THE MUCOSA. TWO (2) LONG CLIPS MALFUNCTIONED IN THE SAME MANNER DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO REPORTED PATIENT HARM. THERE WERE TWO (2) OCCURRENCES AT THE FACILITY ON THE SAME DAY WITH FOUR (4) DIFFERENT LONG CLIPS. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341399 ↗
• MalfunctionAug 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, WHEN THE LONG CLIP WAS ACTIVATED, THE CLIP STUCK TO THE APPLICATOR WHEN SHOOTING. IT DID NOT STICK TO THE MUCOSA. TWO (2) LONG CLIPS MALFUNCTIONED IN THE SAME MANNER DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO REPORTED PATIENT HARM. THERE WERE TWO (2) OCCURRENCES AT THE FACILITY ON THE SAME DAY WITH FOUR (4) DIFFERENT LONG CLIPS. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341369 ↗
• MalfunctionAug 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER, DURING A PROCEDURE, WHEN THE LONG CLIP WAS ACTIVATED, THE CLIP STUCK TO THE APPLICATOR WHEN SHOOTING. IT DID NOT STICK TO THE MUCOSA. TWO LONG CLIPS MALFUNCTIONED IN THE SAME MANNER DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO REPORTED PATIENT HARM. THERE WERE TWO OCCURRENCES AT THE FACILITY ON THE SAME DAY WITH FOUR DIFFERENT LONG CLIPS. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341346 ↗