Auto Suture 150462Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521080751), received between Jan 12, 2021 and Mar 8, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES WERE DIFFICULT TO REMOVE WITH THIS INSTRUMENT. THE GRAFTS STAYED STUCK INSIDE AND WERE PULLED OUT. THERE WERE UP TO 500 STAPLES TO REMOVE, MAKING THE WORK LONGER, TEDIOUS, AND PAINFUL FOR THE PATIENT. THIS INSTRUMENT PULLED OUT THE GRAFTS AND PROLONGED PROCEDURE. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18867647 ↗
• MalfunctionMar 8, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES STAYED STUCK EITHER IN THE STAPLE REMOVER OR IN THE GRAFT SKIN, RESULTING IN THE PULLING OUT OF THE GRAFTS. THERE WERE TOO MANY STAPLES TO REMOVE (UP TO 500 PER DRESSING). THE STAPLES OFTEN GOT STUCK EITHER IN THE INSTRUMENT OR IN THE SKIN, CAUSING PAIN FOR THE PATIENT AND AN INCREASE IN THE DURATION OF THE DRESSING PROCEDURE. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18867641 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, STAPLES WERE DIFFICULT TO REMOVE WITH THE INSTRUMENT. THE SHARP TIPS DAMAGED GRAFTS AND INJURED PATIENTS. PATIENTS OFTEN HAD MORE THAN 300 STAPLES TO REMOVE. SINCE THE STAPLE REMOVER WAS DIFFICULT TO HANDLE, THE PROCESS WAS MORE PAINFUL FOR THE PATIENT. ADDITIONALLY, IT OFTEN RESULTED IN PULLING OUT THE PATIENT¿S AUTOGRAFT AND HOMOGRAFT, MAKING THE PROCEDURE MORE PAINFUL AND LONGER. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18862968 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, REMOVING STAPLES WITH THE INSTRUMENT WAS DIFFICULT, AS IT WAS JAMMED UPON REMOVAL. IT TOOK MUCH LONGER TO REMOVE THE STAPLES, AND THE PROCESS SOMETIMES RESULTED IN PULLING OUT THE GRAFTS, LEADING TO LONGER PROCEDURES AND INCREASED PAIN FOR PATIENTS. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18862457 ↗
• MalfunctionMar 7, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PRODUCT DID NOT GO DEEP ENOUGH TO REMOVE THE STAPLE, RESULTING IN JAMS BETWEEN THE STAPLE AND THE PATIENT. THIS CAUSED THE PROCESS OF STAPLE REMOVAL TO TAKE MUCH LONGER, MAKING IT MORE PAINFUL. ADDITIONALLY, IT TOOK MUCH LONGER TO REMOVE ALL THE STAPLES ON BURNED PATIENTS, AS THEY HAD HUNDREDS OF STAPLES TO REMOVE, LEADING TO MORE PAIN FOR THE PATIENT. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18862424 ↗
• MalfunctionFeb 22, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHEN THE SKIN STAPLES WERE REMOVED FROM BURN PATIENTS, THE PRODUCT CAUSED PAIN FOR PATIENTS AND DIFFICULTY IN HANDLING. STAPLES GOT STUCK IN THE STAPLE REMOVER. THE PINCHING QUALITY OF THE STAPLE REMOVER TO OPEN THE STAPLES WAS POOR, AND THE STAPLE REMAINED STUCK IN THE SKIN. THIS SITUATION HARMED THE GRAFTS SPECIFIC TO THE CARE OF SEVERE BURN PATIENTS. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18761363 ↗
• MalfunctionFeb 21, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SKIN STAPLES WERE REMOVED FROM BURN PATIENTS, THE PRODUCT CAUSED PAIN FOR PATIENTS AND DIFFICULTY IN HANDLING. STAPLES GOT STUCK IN THE STAPLE REMOVER. THE PINCHING QUALITY OF THE STAPLE REMOVER TO OPEN THE STAPLES WAS POOR, AND THE STAPLE REMAINED STUCK IN THE SKIN. THIS SITUATION HARMED THE GRAFTS SPECIFIC TO THE CARE OF SEVERE BURN PATIENTS. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18754992 ↗
• MalfunctionAug 8, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A SKIN CLOSURE PROCEDURE, WHEN USING THE DEVICE TO REMOVE THE STAPLES, THE DEVICE MALFUNCTIONED, THE PLASTIC HANDLE OVERLAPS WHEN HANDLED. SOMETIMES THE STAPLE IS NOT REMOVED PROPERLY, CAUSING IT TO TWIST ON THE SKIN, REQUIRING ITS REMOVAL WITH OTHER INSTRUMENTS, CAUSING INJURY AND DISCOMFORT TO THE PATIENT.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 17481606 ↗
• MalfunctionJul 14, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A SKIN CLOSURE PROCEDURE, WHEN USING THE DEVICE TO REMOVE THE STAPLES, THE DEVICE MALFUNCTIONED, THE PLASTIC HANDLE OVERLAPS WHEN HANDLED. SOMETIMES THE STAPLE IS NOT REMOVED PROPERLY, CAUSING IT TO TWIST ON THE SKIN, REQUIRING ITS REMOVAL WITH OTHER INSTRUMENTS, CAUSING INJURY AND DISCOMFORT TO THE PATIENT. ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 17330426 ↗
• MalfunctionJan 12, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN USING THE DEVICE TO REMOVE THE SKIN STAPLES FROM THE LEFT CHEST WALL, THE HANDLE BROKE FOR NO REASON. AS A RESULT, THE STAPLES COULD NOT BE REMOVED TEMPORARILY, AND ANOTHER DEVICE NEEDED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155467 ↗