Premium Surgiclip 134048Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10884521057555), received between Aug 10, 2017 and Dec 30, 2025 — classified as 12 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (94 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 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND SOME CLIPS WERE MALFORMED.

  Patient problems: Insufficient Information

  MAUDE report 23930744 ↗
• MalfunctionDec 17, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY AS THE CLIPS WERE FALLING OUT. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832513 ↗
• MalfunctionSep 2, 2025Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS WERE UNABLE TO LOAD PROPERLY INTO THE JAWS. IT WAS NOTED TISSUES BECAME STUCK TO THE DEVICES WHEN PULLING, AND THE CLIP REMAINED ATTACHED TO THE DEVICE, WHICH TORE THE VESSEL AFTER CLIPPING IN THE THREE DEVICES.

  Patient problems: Tissue Breakdown

  MAUDE report 22945981 ↗
• MalfunctionSep 2, 2025Entrapment of Device; Mechanics Altered; Entrapment of Device; Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIPS WERE UNABLE TO LOAD PROPERLY INTO THE JAWS. IT WAS NOTED TISSUES BECAME STUCK TO THE DEVICES WHEN PULLING, AND THE CLIP REMAINED ATTACHED TO THE DEVICE, WHICH TORE THE VESSEL AFTER CLIPPING IN THE THREE DEVICES.

  Patient problems: Tissue Breakdown

  MAUDE report 22945942 ↗
• MalfunctionJul 29, 2025Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER DURING AN OPEN LIPECTOMY PROCEDURE, THE CLIPS CROSSED AND BROKE OFF. THIS ISSUE OCCURRED ON TWO DEVICES. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644436 ↗
• MalfunctionJul 29, 2025Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER DURING AN OPEN LIPECTOMY PROCEDURE, THE CLIPS CROSSED AND BROKE OFF. THIS ISSUE OCCURRED ON TWO DEVICES. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644398 ↗
• MalfunctionJul 28, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT PRE-OPERATIVELY, ISSUES WERE EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS FOR THE CLIP APPLIER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637092 ↗
• 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 22172086 ↗
• MalfunctionJan 28, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT PREOPERATIVELY, THERE WERE ISSUES EXPERIENCED WITH THE LOADING OR FIRING OF THE TITANIUM CLIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253381 ↗
• MalfunctionDec 27, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE CLIP APPLIER WOULD NOT FOLD THE STAPLER DOWN WHEN IT WAS FIRED.

  Patient problems: Insufficient Information

  MAUDE report 21026391 ↗
• MalfunctionOct 14, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY PROCEDURE, THE DEVICE WAS UNABLE TO CLIP AND WERE ALREADY BENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447177 ↗
• MalfunctionAug 13, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THE CLIP APPLIER GOT STUCK AFTER THE FIRST CLIP AND WAS UNABLE TO DELIVER THE FOLLOWING CLIPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973810 ↗
• MalfunctionJun 28, 2024Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL HIP PROSTHESIS PROCEDURE, SEVERAL CLIPS WERE USED IN WHICH IT DETACHED AND DID NOT R EMAIN ATTACHED TO THE BLOOD VESSELS. THE SURGICAL TIME WAS EXTENDED BY TEN MINUTES. THE CLIP APPLIER WAS CHANGED TO A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633057 ↗
• MalfunctionFeb 16, 2024Mechanical Problem; Fail-Safe Problem; Mechanical Problem; Fail-Safe Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE FIRST CLIP WAS MALFORMED. THE CLIP WAS ALREADY FOLDED BEFORE IT WAS EVEN TAKEN OUT. IT WAS ALSO MENTIONED THAT THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED AFTER THE CLIP MALFORMATION. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18726134 ↗
• MalfunctionFeb 9, 2024Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL CANCER PROCEDURE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE ISSUE OCCURRED IN TWO SETS OF HANDLES AND RELOADS. THE CLIP APPLIER WAS ABLE TO FIRE. HOWEVER, THE CLIP WAS MALFORMED. THE ORVIL ANVIL WAS DIFFICULT TO LOAD INTO THE DEVICE. NEW DEVICES WERE USED TO RESOLVE THE ISSUE. THE SAME CIRCULAR HANDLE WAS USED WITH THE NEW ORVIL ANVIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680369 ↗
• MalfunctionDec 12, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, HOWEVER THERE WERE EXPERIENCED WITH THE LOADING OR FIRING OF THE CLIPS, NONE OF THE CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS AT ANY POINT DURING USE. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314157 ↗
• MalfunctionAug 22, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, REMOVAL SARCOMA, TWO CLIPS CAME OUT AT THE SAME TIME BLOCK THE DEVICE. TWO DEVICES WAS TRIED SAME ISSUE OCCURRED. A NEW DEVICE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597584 ↗
• MalfunctionAug 22, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, REMOVAL SARCOMA, TWO CLIPS CAME OUT AT THE SAME TIME BLOCK THE DEVICE. TWO DEVICES WAS TRIED SAME ISSUE OCCURRED. A NEW DEVICE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597571 ↗
• MalfunctionJul 3, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, PRIOR TO PATIENT USE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT NO CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252971 ↗
• MalfunctionJun 12, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, IN AN OPEN WIDE EXCISION OF MELANOMA IN THE UPPER RIGHT ARM, WHILE IN THE TISSUE DURING THE LAST STEP, THE SURGEON WAS ALE TO SQUEEZE THE HANDLE BUT AFTER THE FIRST CLIP, NO MORE CLIPS COULD BE APPLIED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110089 ↗
• MalfunctionApr 18, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A DIGESTIVE SURGERY, WHEN CLOSING, THE CLIP TURNED, PREVENTING IT FROM CLOSING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762224 ↗
• MalfunctionApr 4, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE WHILE VASCULAR LIGATION, TWO DEVICES WITH DIFFERENT LOT NUMBERS BECAME STUCK AND COULD NOT BE USED NORMALLY. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678110 ↗
• MalfunctionApr 4, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE WHILE VASCULAR LIGATION, TWO DEVICES WITH DIFFERENT LOT NUMBERS BECAME STUCK AND COULD NOT BE USED NORMALLY. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678077 ↗
• MalfunctionJan 23, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN NEPHRECTOMY PROCEDURE, WHILE ON CLIPPING OF THE VESSELS, THE CLIPS LOADED INTO THE JAWS WERE CROOKED AND UNABLE TO BE FIRED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229909 ↗
• MalfunctionOct 24, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, WHEN PUTTING THE CLIPS IN PLACE, THE CLIP APPLIER ONLY WORKED TWICE AND GOT STUCK. A NEW CLAMP WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662338 ↗