AcuClip OMSA8Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521057517), received between Feb 19, 2016 and Mar 21, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT PROCEDURE, THE DEVICE HAD ISSUES WITH THE LOADING OR FIRING OF THE CLIPS, WHEREIN THE CLIPS WERE UNABLE TO BE LOADED PROPERLY INTO THE JAWS AT ANY POINT DURING USE. A NEW DEVICE WAS OPENED IN ORDER TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357922 ↗
• InjuryJun 21, 2016Bent; Entrapment of Device; Bent; Entrapment of Device

  ACCORDING TO THE REPORTER: DURING A LIVING DONOR KIDNEY TRANSPLANT PROCEDURE, THE DEVICES WERE BEING APPLIED TO THE RENAL ARTERY. THE FIRST DEVICE FIRED ONE CLIP OKAY AND THEN THE DEVICE MISFIRED ON THE SECOND CLIP. THE SECOND DEVICE FIRED TWO CLIPS OKAY AND WOULD NOT RELEASE FROM THE ARTERY ON THE THIRD CLIP. HAD TO PULL THE DEVICE OFF WHICH CAUSED A TEAR IN THE TISSUE. THE SURGEON WAS FRUSTRATED AND BENT THE THIRD DEVICE. THE PROCEDURE WAS COMPLETED WITH A STRAIGHT CLIP APPLIER.

  Patient problems: Perforation of Vessels; Tissue Damage

  MAUDE report 5738403 ↗
• InjuryFeb 19, 2016Unintended Ejection; Mechanical Problem; Detachment of Device or Device Component; Unintended Ejection; Mechanical Problem; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT THE CLIPS JUMPED / EJECTED WHEN BEING PLACED ON THE THORACIC NERVE. THEY HAD TO TRY 3 TO 4 TIMES UNTIL IT REMAINED FIXED. THE ISSUE IS THAT THE PATIENT SEEMED NOT TO MAINTAIN SUFFICIENT PRESSURE ON THE NERVE, SO WHEN IT CAME FOR THE CHECKING VISIT, THE PALMAR SWEATING STILL PERSISTED. THERE IS NO DATE SCHEDULED FOR THE REOPERATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5447454 ↗