Premium Surgiclip II 134051Recalls & reported problems

Summary

The FDA's MAUDE database contains 306 adverse event reports that list this exact device (DI 10884521057562), received between Aug 17, 2017 and Sep 29, 2026 — classified as 17 injuries, 289 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (207 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 306 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Mechanics Altered

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

  MAUDE report 50933622 ↗
• MalfunctionSep 29, 2026Mechanics Altered

  It was reported that during a procedure, the surgeon attempted to clip a vessel, the clip applier did not reload when the surgeon attempted to apply a clip. The clip applier damaged the vessel, resulting in bleeding and tissue damage. To resolve the issue, the device was replaced.

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

  MAUDE report 50927059 ↗
• MalfunctionSep 11, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742635 ↗
• MalfunctionSep 11, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742501 ↗
• MalfunctionJun 30, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A CLIP APPLIER WAS USED AND THE CLIP DID NOT BITE WELL. TO RESOLVE THE ISSUE, A NEW CLIP APPLIER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671125 ↗
• MalfunctionJun 9, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN BREAST RECONSTRUCTION PROCEDURE, WHEN THE CLIP APPLIER WAS APPLIED TO BREAST TISSUE DURING DISSECTION. THE HANDLE WAS ABLE TO BE SQUEEZED AND THE JAWS WERE ABLE TO CLOSE AND THERE WAS A CLIP FORMATION. NOTHING WAS DONE TO RESOLVE THE ISSUE IN ORDER 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 25448910 ↗
• MalfunctionApr 28, 2026

  MEDIUM CLIP DID NOT FIRE CORRECTLY. THE CLIP SCISSORED AND DID NOT CLAMP THE VESSEL PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014561 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING AN OPEN VASCULAR SURGICAL PROCEDURE, SOME OF THE CLIPS DID NOT FORM PROPERLY. THE CASE WAS COMPLETED BY USING MORE CLIPS OF THE SAME REFERENCE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911327 ↗
• MalfunctionApr 16, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A TOTAL PANCREATECTOMY, THE CLIP WAS NOT LOADING.

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

  MAUDE report 24903936 ↗
• MalfunctionMar 31, 2026Mechanics Altered

  IT WAS REPORTED THAT, DURING AN OPEN PROCEDURE, THE HANDLE COULD BE SQUEEZED AND THE JAWS COULD CLOSE, BUT CLIPS COULD NOT BE FIRED AND THERE WERE ISSUES WITH LOADING OR FIRING OF THE CLIPS, ALTHOUGH CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS AT SOME POINT DURING USE. A PRODUCT EXCHANGE WAS PERFORMED 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 24746604 ↗
• MalfunctionMar 30, 2026Device Slipped; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN TRACHEOSTOMY PROCEDURE, THE DEVICE WAS APPLIED TO A VESSEL AND THE CLIP DETACHED FROM THE VESSEL A FEW MINUTES AFTER APPLICATION. THE APPLICATOR DID NOT PROPERLY RELEASE THE CLIP ONTO THE VESSEL, RESULTING IN VESSEL INJURY. IT WAS NOTED THAT TWO DEVICES WERE USED AND HAD THE SAME ISSUE. TO RESOLVE THE ISSUE, REMOVAL OF LIGATURES FROM THE OPERATIVE FIELD WAS DONE AND REPLACEMENT WITH DISPOSABLE CLIPS; LIGATION OF THE VESSEL USING BONDED SUTURE; AND VESSEL CAUTERIZATION USING BIPOLAR ELECTROCAUTERY.

  Patient problems: Perforation of Vessels

  MAUDE report 24736190 ↗
• MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CAROTID ENDARTERECTOMY PROCEDURE, THE DEVICE FAILED TO ACHIEVE CORRECT HEMOSTASIS. IT CLIPS AT FIRST AND LATER FAILED, ADDITIONALLY AFTER CLOSING, BLEEDING OCCURRED. A LARGER NUMBER OF CLIPS THAN EXPECTED WERE USED WITHOUT GUARANTEEING RELIABLE HEMOSTASIS. THE OPERATING TIME WAS EXTENDED AS A RESULT. A NEW DEVICE FROM ANOTHER SUPPLIER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24714353 ↗
• MalfunctionMar 6, 2026Break; Entrapment of Device; Fail-Safe Problem

  IT WAS REPORTED THAT DURING AN OPEN INGUINAL CURETTAGE PROCEDURE, AFTER A FEW CLIPS, THE DEVICE JAWS LOCKED ONTO THE TISSUE, AND THE HANDLE PHYSICALLY BROKE, RESULTING IN NO CLIPS BEING DISPENSED. THE ISSUE WAS RESOLVED BY USING ANOTHER DEVICE 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 24533833 ↗
• MalfunctionFeb 26, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN DUODENAL RESECTION, WHILE IN THE VESSEL, THE HANDLE WAS SQUEEZED BUT NONE OF THE CLIPS WERE ABLE TO LOAD PROPERLY ONTO THE JAWS. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452461 ↗
• MalfunctionFeb 19, 2026Device Slipped

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CLIP DID NOT HOLD WELL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393626 ↗
• MalfunctionFeb 11, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON PREPARATION, THE CLIP DID NOT LOAD. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314194 ↗
• MalfunctionFeb 6, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING WAS FAULTY. 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 24277782 ↗
• MalfunctionJan 22, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAWS OF THE CLIP APPLIER DID NOT BITE. 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 24152337 ↗
• MalfunctionJan 13, 2026Mechanics Altered

  IT WAS REPORTED THAT ISSUES WERE EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS DURING USE OF THE CLIP APPLIER, INCLUDING FIRING BEING FAULTY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND 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 24056219 ↗
• MalfunctionJan 12, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN OPEN SPINE PROCEDURE, THE TWO CLIPS SCISSORED AND ONE OR MORE CLIPS DISENGAGED INTO THE CAVITY OF THE PATIENT. THE CLIPS WERE SUBSEQUENTLY RETRIEVED FROM THE PATIENT. THE SAME INSTRUMENT WAS USED 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 24036578 ↗
• MalfunctionDec 19, 2025Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS AN ISSUE EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS.

  Patient problems: Insufficient Information

  MAUDE report 23858087 ↗
• MalfunctionNov 24, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CLIP DID NOT COME OUT. A NEW DEVICE WAS USED 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 23638372 ↗
• MalfunctionNov 24, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, A CLIP WAS MISALIGNED. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE AND 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 23633212 ↗
• MalfunctionNov 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE CLIP APPLIER, THE CLIP DID NOT COME OUT WELL. A NEW CLIP APPLIER WAS USED TO RESOLVE THE ISSUE AND 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 23568308 ↗
• MalfunctionOct 30, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS, THE CLIP DID NOT COME OUT WHEN THE DEVICE WAS USED. A NEW DEVICE 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 23429652 ↗