Premium Surgiclip 134044Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10884521057531), received between Sep 1, 2017 and Mar 23, 2022 — classified as 2 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (56 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, THE DEVICE CAN¿T USED AFTER WHEN USED 10 FIRING. TO RESOLVE THE ISSUE, THE SURGEON USED A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860508 ↗
• MalfunctionJan 31, 2022Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE SURGEON FIRES THE CLIP, IT NEEDS TO BE ENGAGED, BUT IT BECOMES A U-SHAPE.

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

  MAUDE report 13402574 ↗
• InjuryNov 22, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REMOVAL, WHEN A VESSEL WAS SET DOWN, THERE WAS NO CLIP IN THE BRANCH AND IT CUT THROUGH THE VESSEL. THE INCISION WAS EXTENDED FOR MORE THAN 1 INCH. THERE SEVERED VESSEL WAS SEWN BACK TOGETHER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12851664 ↗
• MalfunctionNov 15, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLES ON THE TWO DEVICES BUT THE CLIPS WERE UNABLE TO FIRE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12813424 ↗
• MalfunctionOct 27, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A SEGMENTAL MASTECTOMY, THE SURGEON WAS ABLE TO USE INITIALLY BUT THEN THEY STOPPED WORKING. BOTH APPLICATORS HAVE THE SAME LOT NUMBER. THEY FIRED THE DEVICE AFTER AND FOUND WITH ONE OF THEM THE STAPLE CROSSED (THE CLIP LYING ACROSS INSTEAD OF WITH SHARP TIP TO THE FRONT). NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705992 ↗
• MalfunctionOct 27, 2021Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A SEGMENTAL MASTECTOMY, THE SURGEON WAS ABLE TO USE INITIALLY BUT THEN THEY STOPPED WORKING. BOTH APPLICATORS HAVE THE SAME LOT NUMBER. THEY FIRED THE DEVICE AFTER AND FOUND WITH ONE OF THEM THE STAPLE CROSSED (THE CLIP LYING ACROSS INSTEAD OF WITH SHARP TIP TO THE FRONT). NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704868 ↗
• MalfunctionAug 10, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE CLIP OF THE CLIP APPLIER WAS CHEWED OUT AND GOT STUCK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302896 ↗
• MalfunctionAug 2, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, WHILE LIGATING SMALL VESSELS AROUND THE TONGUE ON A GLOSSECTOMY, THE CLIPS ON TWO DEVICES MALFORMED. THERE WERE ALSO ISSUE WITH LOADING OR FIRING THE CLIPS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258859 ↗
• MalfunctionJul 27, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS.

  Patient problems: Insufficient Information

  MAUDE report 12232905 ↗
• MalfunctionJul 27, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST PROCEDURE, THE SURGEON EXPERIENCED ISSUE WITH LOADING AND FIRING OF THE CLIPS ON TWO (2) DEVICE. IN ADDITION CLIPS CAME OUT BROKEN. THIRD CLIP APPLIER WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226279 ↗
• MalfunctionMay 18, 2021Mechanical Problem; Material Deformation; Mechanics Altered; Mechanical Problem; Material Deformation; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING, WHEN LIGATING THE SMALL VESSELS, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS WERE NOT LOADING PROPERLY INTO THE JAWS OF THE DEVICE, THERE WERE MALFORMED CLIPS AND SOME CLIPS WERETWISTED INTO AN X-SHAPE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842768 ↗
• MalfunctionApr 29, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING LIGATING SMALL VESSELS IN A CORONARY ARTERY BYPASS GRAFTING, SURGEON COULD NOT SQUEEZE THE HANDLE OF ONE REPORTED CLIP APPLIER. ANOTHER CLIP APPLIER HAD POOR STAPLE FORMATION. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746081 ↗
• MalfunctionApr 28, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LIGATING SMALL VESSELS IN A CORONARY ARTERY BYPASS GRAFTING, SURGEON COULD NOT SQUEEZE THE HANDLE OF ONE REPORTED CLIP APPLIER. ANOTHER CLIP APPLIER HAD POOR STAPLE FORMATION. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739529 ↗
• MalfunctionJan 25, 2021Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN LIGATING SMALL VESSELS AROUND PANCREAS DURING AN OPEN DISTAL PANCREATECTOMY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS. CLIPS WERE ALSO MALFORMED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11223037 ↗
• MalfunctionDec 27, 2020Mechanical Problem; Mechanics Altered; Mechanical Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, UPON LIGATING SMALL VESSELS, THE SURGEON WAS ABLE TO SQUEEZE THE BUT THERE WAS ISSUE IN FIRING THE CLIPS AND SOME OF THESE CLIPS MALFORMED. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074158 ↗
• MalfunctionNov 6, 2020Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  ACCORDING TO THE REPORTER, WHEN LIGATING THE VESSELS AROUND THE HEART ON AN OPEN CORONARY ARTERY BYPASS GRAFTING, THERE WERE SOME MALFORMED CLIPS AND WERE FALLING OFF THE TARGETED VESSEL. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10803879 ↗
• MalfunctionSep 15, 2020Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING OPEN MYOMECTOMY, WHEN FIRING THE CLIPS, IT ENGAGED OBLIQUELY RATHER THAN VERTICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10533842 ↗
• MalfunctionAug 7, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE. THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377888 ↗
• MalfunctionJun 3, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A CLIP MALFORMATION.

  Patient problems: No Information

  MAUDE report 10114344 ↗
• MalfunctionMay 29, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE OPEN PROCEDURE, THE SURGEON COULD NOT PROPERLY LOAD THE CLIP INTO THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101164 ↗
• MalfunctionMay 26, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN HEPATECTOMY, WHILE LIGATING A VESSEL, THE CLIPS DID NOT FORM CORRECTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 10090437 ↗
• MalfunctionMay 8, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING OPEN HEPATIC SEGMENTECTOMY, UPON LIGATING HEPATIC VESSELS, SOME OF THE CLIPS WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037325 ↗
• MalfunctionApr 12, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A HEPATECTOMY PROCEDURE, WHILE TRANSECTING FISSURE AND LIGATING VESSELS, THE CLIP DID NOT LOAD PROPERLY. ANOTHER DEVICE WAS USED THAT HAD THE SAME ISSUE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9951913 ↗
• MalfunctionFeb 28, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN LIGATING THE VESSELS THE CLIPS WERE NOT FULLY LIGATED.

  Patient problems: No Information

  MAUDE report 9771204 ↗
• MalfunctionFeb 28, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN HEPATECTOMY, WHILE ON HEPATIC VESSEL, THERE WERE ISSUES EXPERIENCED WITH LOADING/FIRING OF THE CLIPS. NO CLIPS ABLE TO BE LOAD PROPERLY INTO THE JAWS AT ANY POINT DURING USE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771183 ↗