Premium Surgiclip 134046Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10884521057548), received between Mar 28, 2017 and Aug 26, 2021 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (24 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS.

  Patient problems: Insufficient Information

  MAUDE report 12375269 ↗
• MalfunctionAug 26, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRST CLIP APPLIER HAD AN UNKNOWN ISSUE, THE SECOND CLIP APPLIER HAD ISSUES WITH LOADING OR FIRING OF THE CLIPS.

  Patient problems: Insufficient Information

  MAUDE report 12369078 ↗
• MalfunctionAug 2, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, WHILE LIGATING THE SMALL VESSELS, THE DEVICE WAS ABLE TO BE FIRED. SOME CLIPS FORMED CORRECTLY, BUT SOME OF THE CLIPS WERE MALFORMED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED BY THE SURGEON TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258794 ↗
• MalfunctionMay 7, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, THE CLIP WAS STUCK DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11789498 ↗
• MalfunctionMar 16, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, ON AN OPEN BUCCAL CANCER RESECTION, DURING VESSEL LIGATION, THE CLIP COULD NOT CLOSE COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494866 ↗
• MalfunctionJan 19, 2021Difficult to Open or Close; Mechanics Altered; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING PREPARATION TO LIGATE DIFFERENT VESSELS ON A NECK DISSECTION, NO CLIP WAS LOADED AFTER THE HANDLE WAS SQUEEZED TWICE. A CLIP WAS LOADED BUT COULD NOT PLACE IT. THEY WERE NOT ABLE TO FIRE THE CLIP AS IT WAS STUCK ON THE APPLICATOR. IT WAS STATED THAT THE JAWS WAS NOT ABLE TO CLOSE. ANOTHER CLIP APPLIER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11195265 ↗
• MalfunctionDec 21, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN BARCO (HEAD AND NECK) PROCEDURE FOR CANCER, NO CLIPS WERE ABLE TO BE FIRED FROM THE DEVICE, THE CLIPS WERE STUCK. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11048181 ↗
• MalfunctionDec 15, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN CVC PROCEDURE, WHEN THE SURGEON TRIED TO USE THE DEVICE TO LIGATE THE VESSEL, THE CLIPS WERE ALL STUCK. THE SURGEON THEN USED ANOTHER DEVICE 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 11012033 ↗
• MalfunctionDec 15, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN CVC PROCEDURE, WHEN THE SURGEON TRIED TO USE THE DEVICE TO LIGATE THE VESSEL, THE CLIPS WERE ALL STUCK. THE SURGEON THEN USED ANOTHER DEVICE 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 11011969 ↗
• MalfunctionDec 1, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER RESECTION PROCEDURE, THE SURGEON EXPERIENCE LOADING/FIRING ISSUE OF THE CLIPS. THE SURGEON THEN USED ANOTHER DEVICE 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 10928627 ↗
• MalfunctionOct 26, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A BACON CANCER RESECTION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE ON THE TWO DEVICES, THE JAWS DID NOT CLOSE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10734904 ↗
• MalfunctionAug 7, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN OPENING THE CLIPS DURING AN OPEN THYROIDECTOMY, SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND JAWS WERE ABLE TO CLOSE BUT THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10381316 ↗
• MalfunctionMay 8, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON AN OPEN FLAP SURGERY, WHILE LIGATING VESSELS UNDERNEATH THE SKIN, THERE WERE NO CLIPS COMING OUT OF THE JAW OF THE DEVICE WHEN THE SURGEON SQUEEZED THE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10038212 ↗
• MalfunctionJan 27, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN DISTAL PANCREATECTOMY PROCEDURE, THE DEVICE CLIP COULD NOT LOAD INTO THE JAW. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632167 ↗
• MalfunctionNov 12, 2019Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN LIGATING THE PANCREATIC VESSELS IN A DISTAL PANCREATECTOMY PROCEDURE, THE DEVICE HAD AN ISSUE WITH LOADING OR FIRING OF THE CLIPS AND SOME CLIPS WERE MALFORMED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309895 ↗
• MalfunctionNov 7, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING VESSEL SEALING ON AN OPEN ENTERITIS PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT DEVICE SEEMED TO BE STUCK AFTER FIRING FEW CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289634 ↗
• MalfunctionOct 31, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR ENTERITIS, WHILE CLIPPING THE VESSEL THE SURGEON ABLE TO SQUEEZE THE HANDLE, HOWEVER THERE WERE ISSUE WITH LOADING AND FIRING OF THE CLIPS. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9263749 ↗
• MalfunctionOct 14, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, THERE WAS A POOR CLIP FORMATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187898 ↗
• MalfunctionJul 9, 2019Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A FLAP SURGERY, WHILE LIGATING SMALL VESSELS, THE SURGEON EXPERIENCED ISSUES IN LOADING AND FIRING OF THE CLIPS. IT WAS NOTED THAT CLIPS DEPLOYED FROM THE DEVICE WERE MALFORMED. SAME ISSUE OCCURRED WHEN THE SURGEON USED A SECOND CLIP APPLIER OF THE SAME KIND. SURGEON USED A THIRD CLIP APPLIER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771957 ↗
• MalfunctionJul 9, 2019Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING DISTAL PANCREATECTOMY, WHILE LIGATING SMALL VESSELS AROUND THE PANCREAS, SURGEON EXPERIENCED ISSUES WITH THE LOADING OR FIRING OF THE CLIPS. CLIPS THAT DEPLOYED WERE MALFORMED. THEY USED ANOTHER CLIP APPLIER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771909 ↗
• InjuryJul 1, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING LIGATION IN AN OPEN VARICOCELE PROCEDURE, THERE WAS MISFIRING OF SOME OF THE CLIPS WHICH LED TO BLEEDING. SOME OF THE CLIPS WERE MALFORMED. IT WAS NOTED THAT THE SURGEON HAD MANAGED THE BLEEDING BY SUTURING.

  Patient problems: No Code Available

  MAUDE report 8751305 ↗
• MalfunctionApr 16, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS SURGERY, THE DEVICE GOT STUCK AFTER FIRING A FEW CLIPS. THEY TRIED TO USE TWO DEVICES OF THE SAME PRODUCT ID BUT STILL THEY EXPERIENCED THE SAME SITUATION. A FOURTH DEVICE OF THE SAME PRODUCT ID WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520723 ↗
• MalfunctionJan 22, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON COULD SQUEEZE THE JAWS AND CLIPS WERE ABLE TO BE LOADED PROPERLY, BUT THE CLIPS COULD NOT BE FORMED CORRECTLY AS THE JAWS WERE TWISTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8268215 ↗
• MalfunctionJan 10, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS ABOUT TO LIGATE THE VESSEL DURING AN OPEN HEPATECTOMY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND JAWS WERE ABLE TO CLOSE BUT THERE WAS A PROBLEM LOADING OR FIRING OF THE CLIPS. THEY CHANGED THE DEVICE TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235552 ↗
• MalfunctionJan 3, 2019Mechanics Altered; Physical Resistance/Sticking; Mechanics Altered; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING AN OPEN SKIN GRAFT, WHEN THE DOCTOR USED THE DEVICES TO LIGATE THE VESSEL, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS. IT WAS REPORTED THAT AFTER THE DOCTOR SQUEEZED THE HANDLES OF THE DEVICES, THE HANDLES WERE STILL ABLE TO BE SQUEEZED BUT DID NOT RETURN. THE JAWS WERE STILL ABLE TO CLOSE, BUT NO CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS. THE DEVICES WERE CHANGED TO ANOTHER ONE TO FINISH THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8214913 ↗