NA ETHER320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888551018937), received between Aug 16, 2019 and Jun 16, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Form Staple” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2021Failure to Form Staple; Patient Device Interaction Problem; Failure to Form Staple; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) USING THE REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM WITH LARGE CLIPS (ETHER320/UNKNOWN LOT #) AND TOWARDS THE END OF THE PROCEDURE A CLIP FELL OFF THE TISSUE. THE BLEEDING INITIALLY WAS STOPPED WITH THE CLIP HOWEVER TOWARDS THE END OF THE CASE AFTER LOOKING BACK AT THE ILIAC VEIN, IT WAS OBSERVED THAT THE CLIP HAS FALLEN OFF THE TISSUE AND LATER FOUND IN THE PATIENT¿S ABDOMEN NOT CLIPPED TO ANYTHING. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BLEEDING WAS CAUSED AS THE CLIP DID NOT HOLD AND FELL OFF THE TISSUE. CLIP NOT HOLDING DURING THE PROCEDURE IS A REPORTABLE MALFUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12010893 ↗
• InjuryJun 16, 2021Failure to Form Staple; Patient Device Interaction Problem; Failure to Form Staple; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM WITH LARGE CLIPS (ETHER320/UNKNOWN LOT #) AND ENCOUNTERED INCREASED BLEEDING INTRAOPERATIVELY AS THREE DIFFERENT CLIPS FELL OFF AFTER THEY WERE APPLIED. FURTHERMORE, IT WAS REPORTED THAT THE REFURBISHED CLIP APPLIER ONLY INCLUDED TEN CLIPS, AS OPPOSED TO THE ORIGINAL CLIP APPLIER WHICH CONTAINS 30 CLIPS. THE REPORTER STATES THAT CONSEQUENTLY THERE IS A DELAY IN CARE WHEN THE PHYSICIANS RUN OUT OF CLIPS MUCH SOONER THAN ANTICIPATED AS THE PATIENT CONTINUES TO BLEED WHILE ANOTHER APPLIER HAS TO BE OPENED. AS PER THE REPORT, THE ORIGINAL CLIP APPLIER DID NOT HAVE CLIPS FALL OFF THE TISSUE AND DID NOT NEED TO HAVE MULTIPLE APPLIERS OPENED THROUGHOUT THE CASE. AT THIS TIME, NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, THE EVENT OF INCREASED BLEEDING WAS CAUSED AS THREE DIFFERENT CLIPS ¿FELL OFF¿ AFTER THEY WERE APPLIED DURING THE PROCEDURE. CLIP NOT HOLDING DURING THE PROCEDURE IS A REPORTABLE MALFUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12010779 ↗
• InjuryJun 16, 2021Failure to Form Staple; Patient Device Interaction Problem; Failure to Form Staple; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) USING THE REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM WITH LARGE CLIPS (ETHER320/UNKNOWN LOT #) AND THE CLIPS DID NOT HOLD AND FELL OFF THE TISSUE. THE SURGEON USED AN ENTIRE REPROCESSED CLIP APPLIER HOWEVER THE DEVICE DID NOT FUNCTION AS INTENDED TO STOP THE BLEEDING. A BRAND-NEW CLIP APPLIER (NOT REFURBISHED) WAS OPENED, AND BLEEDING WAS STOPPED AFTER APPLYING ONE CLIP. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME. BASED ON THE INFORMATION PROVIDED, THE EVENT OF BLEEDING WAS CAUSED AS THE CLIPS DID NOT HOLD AND FELL OFF THE TISSUE. CLIP NOT HOLDING DURING THE PROCEDURE IS A REPORTABLE MALFUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12010778 ↗
• InjuryDec 23, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH A REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS AND SUFFERED A BILE LEAK. A REPROCESSED CLIP APPLIER WAS OPENED WITH 10 CLIPS INSIDE. THE SURGEON CLIPPED THE DUCT OF THE GALLBLADDER AND WHEN HE MANIPULATED THE GALLBLADDER THE CLIPS FELL OFF, LEAKING A LARGE AMOUNT OF BILE INTO THE ABDOMEN. THE GALLBLADDER WAS REMOVED QUICKLY, AND THE GALLBLADDER WAS EXTRACTED. THE PATIENT HAD A DRAIN INSERTED DUE TO THE LEAKAGE AND SURGEON FELT LIKE PATIENT NEEDED TO BE ADMITTED BECAUSE OF THE LEAKAGE. THE PATIENT WAS ADMITTED TO HOSPITAL FOR OVERNIGHT MONITORING AND HAS FULLY RECOVERED.

  Patient problems: Fluid Discharge

  MAUDE report 9512311 ↗
• InjuryDec 18, 2019Device Fell

  A REPROCESSED CLIP APPLIER WAS OPENED WITH 10 CLIPS IN IT. THE SURGEON CLIPPED THE DUCT OF THE GALLBLADDER AND WHEN HE MANIPULATED THE GALLBLADDER THEY FELL OFF, LEAKING A LARGE AMOUNT OF BILE INTO THE ABDOMEN. THE GALLBLADDER WAS REMOVED QUICKLY AND THE GALLBLADDER WAS EXTRACTED. THE PATIENT HAD A DRAIN INSERTED DUE TO THE LEAKAGE. SURGEON FELT LIKE PATIENT NEEDED TO BE ADMITTED BECAUSE OF THE LEAKAGE.

  Patient problems: No Code Available

  MAUDE report 9488490 ↗
• MalfunctionAug 16, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS AND A CLIP MALFORMATION OCCURRED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901853 ↗