Premium Surgiclip II 134053Recalls & reported problems

Summary

The FDA's MAUDE database contains 256 adverse event reports that list this exact device (DI 10884521057579), received between Aug 10, 2017 and Sep 30, 2026 — classified as 17 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (146 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 25 most recent of 256 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952170 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936571 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component; Material Deformation; Mechanics Altered; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PREMIUM CLIP APPLIER WAS USED DURING AN OPEN MASTECTOMY AND RECONSTRUCTION WITH FLAPS WHEN THE PHYSICIAN ATTEMPTED TO CLIP VESSELS DURING THE MASTECTOMY. A CLIP LOADING OR FIRING ISSUE WAS REPORTED, AND THE CLIPS WERE DESCRIBED AS MALFORMED IN A Y-SHAPE WHEN RELEASED/DEPLOYED. CLIPS WERE REPORTED TO HAVE DISENGAGED AND FALLEN INTO THE PATIENT CAVITY AFTER DEPLOYMENT; THE CLIPS WERE VISIBLE AND WERE RETRIEVED WITH AN INSTRUMENT. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE FROM THE SAME LOT WAS OPENED AND HAD THE SAME ISSUE, AND THEN ANOTHER CLIP APPLIER FROM A DIFFERENT LOT WAS OPENED AND WORKED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25403200 ↗
• MalfunctionApr 28, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS SURGERY (CABG), DURING BLOOD VESSEL TREATMENT, WHEN LOADING THE CLIP, THE CLIP PROTRUDES OUT OF THE JAW. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022114 ↗
• MalfunctionApr 23, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN WIDE LOCAL EXCISION (WLE) WITH SENTINEL LYMPH NODE BIOPSY (SNB), THE CLIPS ABLE TO LOAD PROPERLY INTO THE JAWS. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. A NEW APPLIER WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969056 ↗
• InjuryApr 20, 2026Device Slipped

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE CLIP FAILED AFTER THE PROCEDURE BECAUSE IT DID NOT REMAIN ON THE PATIENT. THE PATIENT EXPERIENCED A HEMORRHAGE DUE TO CLIP DISLODGEMENT, WHICH REQUIRED AN URGENT POSTOPERATIVE RE-OPERATION. ANOTHER CLIP WAS USED TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24933937 ↗
• InjuryApr 11, 2026Device Slipped; Material Deformation

  IT WAS REPORTED THAT DURING AN OPEN HEMITHYROIDECTOMY PROCEDURE, THE DEVICE WAS APPLIED TO VESSELS AND DID NOT CLOSE PROPERLY. UPON VISUAL INSPECTION, THE CLIPS WERE CROSS LIKE A SCISSOR. THIS RESULTED IN BLEEDING AND ANTERIOR JUGULAR VEIN INJURY. THE SURGICAL TIME WAS REPORTED TO HAVE BEEN EXTENDED MORE THAN 30 MINUTES. IT WAS ALSO NOTED THAT THERE WAS HEMATOMA IMMEDIATELY AFTER EXTUBATION. THE PATIENT WAS RE-INTUBATED AND HEMATOMA EVACUATION WAS DONE, THERE WERE MULTIPLE LOOSE CLIPS. THE PATIENT WAS REPORTED TO STILL BE HOSPITALIZED. TO COMPLETE THE CASE, ANOTHER CLIP FROM A DIFFERENT MANUFACTURER WAS OPENED AND USED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 24847803 ↗
• MalfunctionMar 30, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A THORACOTOMY ANEURYSMECTOMY, DURING VASCULAR CLIP, FROM THE FIRST FIRING, THE CLIP WAS TWISTED AND FIRING COULD NOT BE PERFORMED ACCURATELY. IT WAS NOTED THAT EVEN AFTER IT WAS CHECKED WITH AN ADDITIONAL 2¿3 SHOTS, CLIP COULD NOT BE DONE. A NEW PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729856 ↗
• MalfunctionFeb 21, 2026Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LIVER RESECTION, THE CLIPS WERE CROSSING/OVERLAPPING WHEN APPLIED. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410426 ↗
• MalfunctionFeb 19, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANTATION, WHEN THE HANDLE WAS SQUEEZED, THE CLIPS WERE NOT APPEARING AND NOT LOADING PROPERLY. THIS ISSUE OCCURRED ON FOUR DEVICES. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394034 ↗
• MalfunctionFeb 18, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANTATION, WHEN THE HANDLE WAS SQUEEZED, THE CLIPS WERE NOT APPEARING AND NOT LOADING PROPERLY. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376531 ↗
• MalfunctionFeb 18, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANTATION, WHEN THE HANDLE WAS SQUEEZED, THE CLIPS WERE NOT APPEARING AND NOT LOADING PROPERLY. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376523 ↗
• MalfunctionFeb 18, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANTATION, WHEN THE HANDLE WAS SQUEEZED, THE CLIPS WERE NOT APPEARING AND NOT LOADING PROPERLY. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376463 ↗
• InjuryFeb 2, 2026Material Deformation; Firing Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN PROCEDURE, ALL THE CLIPS THAT WERE FIRED WERE TWISTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 24240323 ↗
• MalfunctionJan 15, 2026Mechanics Altered

  IT WAS REPORTED THAT PREOPERATIVELY, THE CLIP COULD NOT BE LOADED, THE JAWS ONLY CLOSED WHEN THE HANDLE WAS SQUEEZED, WHICH RESULTED IN DRY FIRING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086314 ↗
• MalfunctionDec 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN HEMIHEPATECTOMY PROCEDURE, DURING LIVER RESECTION, EVERY SECOND CLIP WAS BENT AND THE CLOSURE WAS INSUFFICIENT. SOME CLIPS WERE REMOVED WITH FORCEPS. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921445 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN OPEN THYROIDECTOMY, WHEN APPLIED TO A VESSEL, BLEEDING OCCURRED DUE TO IMPROPER CLOSING AND CROSSING OF THE CLIP. THERE WAS BLOOD LOSS OF LESS THAN 500CC. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A DIFFERENT COMPANY CLIP APPLIER WAS OPENED TO ACHIEVE PROPER HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23711447 ↗
• MalfunctionOct 15, 2025Difficult to Open or Close; Mechanics Altered; Firing Problem; Difficult to Open or Close; Mechanics Altered; Firing Problem

  IT WAS REPORTED THAT DURING A MASTECTOMY, THE CLIPS NOT LOADING PROPERLY INTO THE JAWS AT ANY POINT DURING USE. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED, BUT THE JAWS DID NOT CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301740 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A FEMORAL ENDARTERECTOMY (OPEN PROCEDURE, BRANCH VESSELS), THE CLIPS KEPT SCISSORING WHEN APPLIED TO TISSUE. ANOTHER CLIP APPLIER WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295065 ↗
• MalfunctionSep 17, 2025Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, TWO CLIP APPLIERS HAD SOME CLIPS JUMP OUT. SOME DID NOT JUMP OUT. SOME CLIPS CLOSED PROPERLY AND SOME DID NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23070755 ↗
• MalfunctionJul 29, 2025Precipitate in Device or Device Ingredient; Mechanics Altered; Precipitate in Device or Device Ingredient; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN LIVER RESECTION INVOLVING SMALL BLOOD VESSELS IN THE LIVER, THE CLIP APPLIER WAS USED AND FINE SLAG FELL FROM THE DEVICE DURING USE. THE TITANIUM CLIP COULD NOT BE FIRED NORMALLY, AND CLIPS WERE NOT ABLE TO LOAD PROPERLY INTO THE JAWS. THE APPLIER COULD BE CLOSED AND THE HANDLE SQUEEZED, BUT AFTER FIRING AND CLOSING, A SIGNIFICANT AMOUNT OF FINE SLAG WAS OBSERVED TO FALL OUT WHILE THE TITANIUM CLIP DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644621 ↗
• MalfunctionJul 10, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PULMONARY NODULE RESECTION, THE CLIP APPLIER WAS ASSOCIATED WITH CLIPS ACCUMULATING AT THE TIP OF THE DEVICE AND NOT COMING OUT. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER DEVICE FROM THE SAME BATCH WAS OPENED AND USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467970 ↗
• MalfunctionJun 12, 2025Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR OPEN-HEART SURGERY, DURING VASCULAR PROCESSING, THE TWO-CLIP APPLIER WAS NOT LOADING PROPERLY. THERE WAS CLIP MALFORMATION AND TWISTING, AND THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196395 ↗
• MalfunctionJun 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A BREAST PROCEDURE, THE CLIP WAS FIRING ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188118 ↗
• MalfunctionJun 9, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN CYSTECTOMY, WHILE CLIPPING THE VASCULAR STRUCTURES, THE HANDLE WAS SQUEEZED AND SOME OF THE CLIPS FROM THE TWO DEVICES CAME OUT MALFORMED. THE MALFORMED CLIPS WERE REMOVED, AND NEW DEVICES WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172091 ↗