Premium Surgiclip 134031Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 20884521057521), received between Mar 15, 2017 and Feb 15, 2023 — classified as 19 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (73 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 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2023Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING A DIGESTIVE PROCEDURE, THE TWO CLIPS INTERSECTED DURING APPLICATION. THE INITIALLY U-SHAPED CLIP FLATTENS AT EACH END IN A PARALLEL FASHION AS NORMAL. OUT THERE, THE CLIPS OVERLAP, EACH END WENT THE OPPOSITE WAY. ANOTHER LIGATURE DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379162 ↗
• InjurySep 7, 2022Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION MAMMOPLASTY, AT THE FOURTH FIRING OF THE CLIP, THE VESSEL WAS NOT CLIPPED BUT CUT. THE VESSEL BEHIND THE STERNUM WAS UNINTENTIONALLY SEVERED. THE SURGEON FIXED THE VESSEL BY SUTURE LIGATION METHOD. THERE WAS A TISSUE DAMAGED. A NEW PRODUCT WAS REPLACED BY A NEW ONE.

  Patient problems: Perforation of Vessels; Unspecified Tissue Injury

  MAUDE report 15374815 ↗
• InjurySep 7, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY, WHILE THE VESSEL WAS CLIPPED DURING THE OPERATION, THE VESSEL WAS UNFORTUNATELY CUT AND NOT CLIPPED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15374810 ↗
• MalfunctionAug 1, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CLIP TENDS TO CUT THE VESSEL RATHER THAN CLAMP IT. SUTURES WERE USED TO COMPENSATE FOR THE USE OF CLIPS AND TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15139507 ↗
• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TUMOR REMOVAL IN THE JAW AREA PROCEDURE, WHEN REMOVING FROM A VESSEL, A CLIPS FELL IN THE PATIENT CAVITY. THE SURGEON WAS ABLE TO RETRIEVED THE CLIP. TO RESOLVE THE ISSUE, A NEW CLIP APPLIER FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15017171 ↗
• InjuryJun 3, 2022Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, AFTER FIRING THE DEVICE, THE CLIP CUT A VESSEL AND IT WAS BLEEDING. SURGEON SUTURED THE VESSEL TO STOP BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14593632 ↗
• MalfunctionMay 4, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN GYNECOLOGY BREAST SURGERY, THE CLIPS WERE PUT ACROSS THE CLAMP AT EACH USE. THE CLIPS WERE NOT ABLE TO LOAD PROPERLY INTO THE JAWS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281918 ↗
• MalfunctionMay 3, 2022Difficult to Open or Close; Mechanics Altered; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE AFTER A PROCEDURE AND PRIOR TO EXPLANT, THE CLIPS WOULD NOT CLOSE AND WHEN THEY CLOSE, THEY SEVER VESSELS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 14269724 ↗
• MalfunctionMay 3, 2022Difficult to Open or Close; Mechanics Altered; Insufficient Device Problem Information; Difficult to Open or Close; Mechanics Altered; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE AFTER A PROCEDURE AND PRIOR TO EXPLANT, THE CLIPS WOULD NOT CLOSE AND WHEN THEY CLOSE, THEY SEVER VESSELS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 14269708 ↗
• MalfunctionApr 26, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTECTOMY, THERE WERE ISSUES WITH FIRING AND LOADING OF THE CLIPS. THE DEVICE MISFIRED AND THE CLIP WERE NOT FIRING. OPENED ANOTHER PRODUCT AND THE PROCESS WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212785 ↗
• MalfunctionApr 15, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE FIRST CLIP CAME OUT FINE BUT THE SECOND CAME OUT ASKEW. DURING USE, EVERY SECOND CLIP HAD TO BE DISCARDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116688 ↗
• MalfunctionApr 4, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE CLIPS WERE NOT ABLE TO LOAD INTO THE JAWS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000437 ↗
• MalfunctionApr 4, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER DURING AN OPEN CEPHALIC DUODENOPANCREATECTOMY PROCEDURE, WHILE CLAMPING OF THE SUPERIOR MESENTERIC ARTERY, THE CLIP DID NOT CLOSE AND IMPOSSIBLE TO CLAMP THE SUPERIOR MESENTERIC ARTERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995519 ↗
• MalfunctionMar 28, 2022Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING AN OPEN VEIN BYPASSING, WHEN CLIPPING THE VESSEL, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THERE WAS 1 UNSTABLE CLIP FROM THE 1ST DEVICE ON THE VESSEL THAT FELL INTO THE PATIENT CAVITY AND WERE RETRIEVED WITH AN INSTRUMENT. IT WAS NOTED THAT A SECOND CLIP FROM A 2ND PRODUCT WAS ALSO UNSTABLE AND WAS TESTED ON PAPER. THE VESSELS WERE COVERED BY SUTURES TO RESOLVE THE ISSUE AS STANDARD PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 13934358 ↗
• MalfunctionMar 21, 2022Fail-Safe Problem; Mechanics Altered; Fail-Safe Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, ON THE FIRING STEP, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE, THE CLIP APPLIER BLOCKED BEFORE LOADING. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13843759 ↗
• MalfunctionMar 17, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A VARICES PROCEDURE, WHILE CLIPPING THE VESSEL, THE JAW WAS STUCK AFTER ONLY ONE ACTIVATION. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790757 ↗
• InjuryMar 16, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A BREAST SURGERY PROCEDURE, WHILE CLIPPING, NO CLIP WAS PRELOADED INTO THE JAW. NO HEMOSTASIS TOOK PLACE AND THE JAWS SQUEEZED THE VESSEL CAUSING TISSUE DAMAGE. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13790298 ↗
• MalfunctionMar 8, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN PROCTECTOMY AND LAPAROTOMY, ON EACH OF THE 3 CLAMPS, THE 1ST CLIP CAME OUT, BUT THE FOLLOWING ONES DID NOT LOAD. NEW DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13700357 ↗
• MalfunctionFeb 24, 2022Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN RESECTION OF THE COSTOSTERNOCLAVICULAR JOINT, ON VESSEL LIGATION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE; THE CLIPS INITIALLY DID NOT LOAD THEN WERE CROOKED WHEN FIRED. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590734 ↗
• MalfunctionFeb 23, 2022Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT LOAD PROPERLY AND CLIP DID NOT DEPLOY WHEN THE HANDLE WAS SQUEEZED.

  Patient problems: Insufficient Information

  MAUDE report 13585651 ↗
• MalfunctionFeb 23, 2022Component or Accessory Incompatibility; Difficult to Open or Close; Mechanics Altered; Component or Accessory Incompatibility; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE JAWS WAS UNABLE TO CLOSE, AND THE CLIPS WAS DIFFICULT TO LOAD OR FIRE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584098 ↗
• MalfunctionFeb 3, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A VASCULAR RESECTIONS IN THE RELEVANT DISCIPLINES OF VISCERAL AND THORACIC SURGERY, THE CLIPS GOT STUCK AND COULD NOT BE RELEASED AND USED. THE INTERVENTION WAS CONTINUED WITH A NEW CLIP APPLIER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442095 ↗
• MalfunctionJan 27, 2022Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A LIVER RESECTION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS DID NOT COME OUT OF THE APPLICATOR OR CAME SIDEWAYS OUT THE 7 CLIP APPLIERS OR OVERLAPPED AT THE TIP. THE OPERATOR USED NEW ONES, NOTICED THE SAME PROBLEM AND AFTER 5 MALFUNCTIONED PIECES A COMPETITOR'S PRODUCT WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368604 ↗
• MalfunctionJan 27, 2022Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A LIVER RESECTION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS DID NOT COME OUT OF THE APPLICATOR OR CAME SIDEWAYS OUT THE 7 CLIP APPLIERS OR OVERLAPPED AT THE TIP. THE OPERATOR USED NEW ONES, NOTICED THE SAME PROBLEM AND AFTER 5 MALFUNCTIONED PIECES A COMPETITOR'S PRODUCT WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368409 ↗
• MalfunctionJan 7, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LEFT WIDE LOCAL EXCISION AND AXILLARY NODE CLEARANCE, THE USER ASKED FOR THE DEVICE TO CLIP A BLOOD VESSEL, WAS ABLE TO SQUEEZE THE HANDLE, IT WORKED FOR A FEW TIMES AND THEN IT WAS EJECTING CLIPS THAT DID NOT FORM CORRECTLY. A NEW CLIP APPLIER WAS OPENED AS THE PREVIOUS ONE WAS MISFIRING ON THE TIME WHEN THERE WAS BLEEDING OF NOT MORE THAN 500CC ON THE VESSELS. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195399 ↗