Appose ULC 8886803712Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10884521104372), received between Jul 8, 2016 and Aug 6, 2026 — classified as 8 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  Patient problems: Laceration(s)

  MAUDE report 50161193 ↗
• MalfunctionMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY FOR THE THREE SKIN STAPLERS. ABSORBABLE SUTURE WAS USED IN ORDER TO CLOSE THE WOUND AND COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25224597 ↗
• MalfunctionMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLES DID NOT CLOSE PROPERLY FOR THE THREE SKIN STAPLERS. ABSORBABLE SUTURE WAS USED IN ORDER TO CLOSE THE WOUND AND COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25224563 ↗
• MalfunctionApr 28, 2026Failure to Align; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, THE STAPLER MISFIRED AND WAS NOT ALIGNED PROPERLY DURING FIRING WHICH CAUSED TISSUE DAMAGE TO THE PATIENT. THE DEVICE USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25011819 ↗
• MalfunctionMar 25, 2026Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IMMEDIATELY AFTER THE SQUEEZE, THE STAPLES BROKE INSIDE THE DEVICE, WHICH SUBSEQUENTLY CAUSED THE JAMMING OF THE MECHANISM. ANOTHER SAME TYPE OF DEVICE FROM THE SAME COMPANY 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 24692042 ↗
• MalfunctionJan 15, 2026Unintended Ejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENTS DEVELOPED WOUND DEHISCENCE BECAUSE THE SKIN STAPLES WERE RELEASED TOO EARLY.

  Patient problems: Wound Dehiscence

  MAUDE report 24079942 ↗
• MalfunctionJan 15, 2026Unintended Ejection; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENTS DEVELOPED WOUND DEHISCENCE BECAUSE THE SKIN STAPLES WERE RELEASED TOO EARLY.

  Patient problems: Wound Dehiscence

  MAUDE report 24079919 ↗
• MalfunctionDec 12, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SKIN STAPLER, THE DEVICE WAS ACTIVATED AND THE STAPLES WERE DEPLOYED; HOWEVER, THE STAPLES FAILED TO PROPERLY ENGAGE OR PENETRATE THE SKIN, RESULTING IN THE WOUND REMAINING OPEN. THE DEVICE MALFUNCTION REQUIRED ADDITIONAL MANIPULATION OF THE WOUND, AND EXTENDED THE SURGERY TIME. ANOTHER SAME TYPE OF DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23786527 ↗
• MalfunctionOct 22, 2025Material Separation; Failure to Form Staple; Material Separation; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, AT SKIN CLOSURE, THE STAPLE BROKE, AND A STAPLE WENT INSIDE WITHOUT BEING CAUGHT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358983 ↗
• MalfunctionSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD SUBCUTANEOUS INFECTION AT THE SITE WHERE THE STAPLES WERE USED FOR SKIN CLOSURE. AN ORAL DOXYCYCLINE COURSE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23009514 ↗
• MalfunctionAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD SUBCUTANEOUS INFECTION AT THE SITE WHERE THE STAPLES WERE USED FOR SKIN CLOSURE. AN ORAL DOXYCYCLINE COURSE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22920620 ↗
• MalfunctionAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST-OPERATIVELY, THE PATIENT HAD SUBCUTANEOUS INFECTION AT THE SITE WHERE THE STAPLES WERE USED FOR SKIN CLOSURE. AN ORAL DOXYCYCLINE COURSE WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22920597 ↗
• MalfunctionAug 27, 2025Break; Mechanics Altered; Break; Mechanics Altered

  ACCORDING TO THE REPORTER PREOPERATIVELY UPON OPENING THE PACKAGING, THE STAPLER BROKE. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 22903521 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE, THE SKIN STAPLER HAD 38 STAPLES IN IT. AN X-RAY WAS TAKEN.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22607898 ↗
• MalfunctionJun 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE TO TREAT A HEAD LACERATION, THE SKIN STAPLER MALFUNCTIONED AND BECAME STUCK IN THE PAT IENT'S HEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22319397 ↗
• MalfunctionMar 5, 2025Entrapment of Device; Failure to Align; Entrapment of Device; Failure to Align

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, AT THE TIME OF STAPLING, THE STAPLE REMAINED STUCK ON THE PATIENT'S SCALP. THERE WAS DIFFICULTY FOR THE SURGEON TO GET IT OFF, AND THE STAPLES APPEARED TO BE POORLY POSITIONED IN THE SKIN STAPLER. ANOTHER SKIN STAPLER FROM A DIFFERENT BATCH PRESENTED THE SAME ISSUE. THE SURGEON REMOVED THE STAPLE FROM THE WOUND AND SUTURED IT IN PLACE. SURGICAL TIME WAS EXTENDED FOR LESS THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21527168 ↗
• MalfunctionMar 5, 2025Entrapment of Device; Failure to Align; Entrapment of Device; Failure to Align

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, AT THE TIME OF STAPLING, THE STAPLE REMAINED STUCK ON THE PATIENT'S SCALP. THERE WAS DIFFICULTY FOR THE SURGEON TO GET IT OFF, AND THE STAPLES APPEARED TO BE POORLY POSITIONED IN THE SKIN STAPLER. ANOTHER SKIN STAPLER FROM A DIFFERENT BATCH PRESENTED THE SAME ISSUE. THE SURGEON REMOVED THE STAPLE FROM THE WOUND AND SUTURED IT IN PLACE. SURGICAL TIME WAS EXTENDED FOR LESS THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21527125 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING.

  Patient problems: Insufficient Information

  MAUDE report 21305873 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING.

  Patient problems: Insufficient Information

  MAUDE report 21305869 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING.

  Patient problems: Insufficient Information

  MAUDE report 21305848 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING.

  Patient problems: Insufficient Information

  MAUDE report 21305325 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING.

  Patient problems: Insufficient Information

  MAUDE report 21304284 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL KNEE ARTHROPLASTY, THE SKIN STAPLES WERE NOT HOLDING AND FELL OUT EASILY PRIOR TO FIRING. A NEW STAPLER WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293526 ↗
• MalfunctionJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPEN BREAST PROCEDURE, IN SKIN CLOSURE, THE SKIN TISSUE TORE UPON THE APPLICATION OF THE STAPLER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21161397 ↗
• MalfunctionMar 27, 2024Break; Entrapment of Device; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component; Break; Entrapment of Device; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE PROCEDURE, ALL SIX DEVICES DISINTEGRATE INTO THEIR INDIVIDUAL PARTS DURING USE, THE INDIVIDUAL STAPLES DO NOT CLOSE COMPLETELY SO THAT THERE WAS NO HOLD IN THE SKIN OR THE WOUND SUTURE DID NOT CLOSE. IT WAS ALSO REPORTED THAT THE STAPLING WAS NOT POSSIBLE OR THE INDIVIDUAL STAPLES GET CAUGHT IN THE DEVICE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18988344 ↗