Appose ULC 8886803512Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10884521104365), received between Aug 26, 2017 and Sep 28, 2026 — classified as 10 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (41 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923742 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT UNDERWENT A CESAREAN SECTION CLOSED WITH A SKIN STAPLER, THE PATIENT DEVELOPED A LOCALIZED POSTOPERATIVE WOUND COMPLICATION CHARACTERIZED BY A SLIGHTLY INFLAMMATORY, WARM BUT PAINLESS NECROTIC AREA (5 CM) AT THE CENTER OF THE SURGICAL SCAR, ALONG WITH A BLISTER AND THE RELEASE OF FOUL-SMELLING SEROSANGUINOUS FLUID FOLLOWING REMOVAL OF TWO STAPLES. THE ADVERSE EVENT REQUIRED SURGICAL INTERVENTION UNDER GENERAL ANESTHESIA, INCLUDING WIDE EXCISION OF NECROTIC TISSUE (2 CM MARGIN) AND DEBRIDEMENT TO HEALTHY TISSUE, FOLLOWED BY TRIPLE ANTIBIOTIC THERAPY, MICROBIOLOGY CULTURES WERE POSITIVE FOR STREPTOCOCCUS ORALIS/MITIS AND STAPHYLOCOCCUS EPIDERMIDIS. SUBSEQUENT MONITORING SHOWED PERSISTENT INFLAMMATION, ELEVATED C-REACTIVE PROTEIN (CRP), AND IMAGING FINDINGS OF A SMALL HYDROAERIC COLLECTION IN THE ABDOMINAL WALL, LEADING TO ADJUSTMENT OF ANTIBIOTIC THERAPY AND CONTINUED CLINICAL OBSERVATION, WITH INVOLVEMENT OF THE HOSPITAL HYGIENE SERVICE FOR INFECTION ANALYSIS.

  Patient problems: Fluid Discharge; Local Reaction; Necrosis; Skin Inflammation/ Irritation; Unintended Radiation Exposure; Unspecified Infection; Wound Odor

  MAUDE report 24911482 ↗
• MalfunctionFeb 12, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE STAPLES FROM THE SKIN STAPLER DID NOT HOLD. THE PATIENT HAD TO TRANSFER TO ANOTHER CLINIC TO REPLACE THE STAPLES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24327788 ↗
• MalfunctionJan 2, 2026Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PARTIAL MASTECTOMY PROCEDURE, IN SKIN CLOSURE, A PARTIALLY DEPLOYED STAPLE WAS STUCK AT THE END OF THE STAPLER AND WAS CAUGHT ON TISSUE. THIS RESULTED IN SKIN DAMAGE. TO RESOLVE THE ISSUE, A NEW STAPLER OF THE SAME TYPE WAS USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23951001 ↗
• InjuryDec 16, 2025Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POSTOPERATIVELY, THE STAPLES WERE PARTIALLY DEPLOYED BUT WERE STUCK IN THE END OF THE STAPLER. THE PATIENT HAD TO COME TO THE EMERGENCY ROOM ON (B)(6) 2024, BECAUSE IT WAS NOT POSSIBLE FOR THE PRIVATE NURSE TO REMOVE THE STAPLES. THE PATIENT EXPERIENCED INTENSE PAIN WHEN THE STAPLES WERE REMOVED AND HAD SKIN LESIONS RELATED TO THE REMOVAL OF STAPLES. ACTIONS WERE TAKEN IN THE HEALTHCARE FACILITY FOR THE MANAGEMENT OF THE PATIENT.

  Patient problems: Localized Skin Lesion; Pain

  MAUDE report 23821090 ↗
• MalfunctionNov 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING USE OF THE SKIN STAPLER, THE DEVICE DID NOT TRIGGER THE STAPLE CORRECTLY AND REMAINED STUCK TO THE SKIN. THE STAPLER WAS CHANGED 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 23529227 ↗
• MalfunctionOct 20, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THE STAPLING OF THE LACERATION TO THE BACK OF THE HEAD, THE SKIN STAPLER MALFUNCTIONED AND GOT STUCK TO THE PATIENT WHILE ATTACHED TO THE STAPLE. AFTER MUCH ADJUSTMENT AND WHEN LIDOCAINE WAS USED TO NUMB THE PATIENT, THE SURGEONS WERE ABLE TO GET THE STAPLER REMOVED FROM THE HEAD. THE DAMAGED SKIN STAPLES WERE REMOVED. THE FIRST STAPLER MISFIRED AT STAPLE NUMBER FOUR. A SECOND STAPLER ALSO HAD THE SAME MALFUNCTION ON STAPLE NUMBER SEVEN. ANOTHER SKIN STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 23335442 ↗
• MalfunctionOct 20, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THE STAPLING OF THE LACERATION TO THE BACK OF THE HEAD, THE SKIN STAPLER MALFUNCTIONED AND GOT STUCK TO THE PATIENT WHILE ATTACHED TO THE STAPLE. AFTER MUCH ADJUSTMENT AND WHEN LIDOCAINE WAS USED TO NUMB THE PATIENT, THE SURGEONS WERE ABLE TO GET THE STAPLER REMOVED FROM THE HEAD. THE DAMAGED SKIN STAPLES WERE REMOVED. THE FIRST STAPLER MISFIRED AT STAPLE NUMBER FOUR. A SECOND STAPLER ALSO HAD THE SAME MALFUNCTION ON STAPLE NUMBER SEVEN. ANOTHER SKIN STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 23335427 ↗
• MalfunctionMay 16, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22040833 ↗
• MalfunctionMay 16, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22040827 ↗
• MalfunctionMay 16, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22040819 ↗
• MalfunctionMay 16, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22040730 ↗
• MalfunctionMay 16, 2025Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL ARM LIFTS AND BILATERAL THIGH LIFTS PROCEDURE, IN SKIN CLOSURE, THE STAPLE SEEMS TO DEPLOYED AND ONE SIDE OF THE STAPLER WAS IN THE EDGE OF THE SKIN AND THE OTHER SIDE WAS STACKED OR JAMMED IN THE DEVICE. THE SURGEON TRIED TO FIRE IT AGAIN TO RELEASE THE SKIN BUT THE STAPLER KEEP JAMMING INSIDE. THE SURGEON HAD TO RELEASE THE STAPLER FROM THE SKIN WITH A MOSQUITO CLIP WHILE THE SKIN WAS JAMMED IN THE TIP OF STAPLER, SO THE EDGE OF THE SKIN WAS SLIGHTLY DAMAGE. THIS ISSUE OCCURRED ON A TOTAL OF FIVE SKIN STAPLERS. IT WAS NOTED THAT THE SURGEON HAD TO CHOOSE A ¿HEALTHY¿( FRESH) SKIN EDGE TO APPLY NEW STAPLERS. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22040720 ↗
• MalfunctionMar 25, 2025Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PARTIAL NEPHRECTOMY DUE TO KIDNEY TUMOR, DURING EPIDERMAL SUTURING, THE SKIN STAPLER WAS USED FOR EPIDERMAL ANASTOMOSIS. DURING THE USE PROCESS, WITHOUT EXTERNAL FACTORS OR IMPROPER OPERATION, ONE OF THE SUTURE STAPLES GOT STUCK. HALF OF THE STAPLE WAS FIXED ON THE PATIENT'S SKIN, AND THE OTHER HALF WAS STUCK ON THE STAPLER AND COULD NOT BE REMOVED. AFTER THAT, A VASCULAR CLAMP WAS USED TO FORCIBLY REMOVE THE PART OF THE STAPLE ON THE SKIN, AND THE SKIN WAS RE-ANASTOMOSED. THIS EVENT CAUSED MINOR SKIN DAMAGE TO THE PATIENT, AND THE STAPLER WAS REPLACED DURING THE OPERATION TO REMEDY THE SITUATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21692023 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A VARICOSE VEIN SURGERY PROCEDURE, WHEN THE USER OPENED THE DEVICE, THE STAPLE WAS ALREADY BROKEN. THE DEVICE WAS NOT THEN USED. TO RESOLVE THE ISSUE, ANOTHER DEVICE OF THE SAME TYPE WAS USED. THIS RESULTED IN AN EXTENDED SURGICAL TIME OF 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126903 ↗
• MalfunctionOct 30, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE PROCEDURE, THE STAPLER REMAINED STUCK IN THE PATIENT'S SKULL, MAKING IT IMPOSSIBLE TO REMOVE THE STAPLER. THIS CAUSED SIGNIFICANT PAIN FOR THE PATIENT. SUTURES WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Pain

  MAUDE report 20571330 ↗
• MalfunctionJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, VETERINARY C-SECTION CLOSING WOUND, THE ANIMAL WENT HOME AND THEN BACK AFTER 3DAYS FOR NEW STAPLES. SOME OF THE STAPLE FELL OFF.

  Patient problems: Wound Dehiscence

  MAUDE report 19543458 ↗
• MalfunctionJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOUR DAYS FOLLOWING A VETERINARY PROCEDURE FOR PYOMETRA (INFLAMED UTERUS) WHEREIN THE STAPLER WAS USED FOR SKIN CLOSURE, THE DOG WAS BROUGHT BACK DUE TO THE STAPLES THAT FELL OFF AND A WOUND INFECTION. THE DOG WAS TREATED FOR WOUND INFECTION AND THE FALLEN STAPLES; SKIN EDGES WERE ¿SCRAPED¿ BY A SCALPEL, THE WOUND WAS FLUSHED WITH NACL (SODIUM CHLORIDE), AND THE INCISION WAS STAPLED WITH SEVERAL NEW STAPLES.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 19539168 ↗
• MalfunctionJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOUR DAYS POSTOPERATIVELY OF A VETERINARY PROCEDURE FOR PYOMETRA (INFLAMMATION IN UTERUS), AT THE WOUND CLOSURE, THERE WAS A WOUND INFECTION AND SOME STAPLES FELL OFF. IT WAS NOTED THAT THERE WAS A TISSUE DAMAGE. TO RESOLVE THE ISSUE, THE PATIENT WOUND WAS FLUSHED WITH SODIUM CHLORIDE.

  Patient problems: Post Operative Wound Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19539128 ↗
• MalfunctionJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS AFTER AN OPEN VETERINARY CESAREAN SECTION PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL BECAUSE SOME STAPLES HAD FALLEN OFF AND FOR WOUND INFECTION TREATMENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19538206 ↗
• MalfunctionMay 17, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE PROCEDURE, WHEN THE DEVICE WAS PRESSED INTO THE PATIENT SCALP, IT DID NOT RELEASE THE STAPLE. THIS RESULTED IN THE STAPLER BECOMING STUCK IN THE PATIENT SCALP. LOCAL ANESTHETIC WAS INSTILLED TO REMOVE THE DEVICE AND THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19342877 ↗
• MalfunctionApr 26, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CHOLECYSTECTOMY PROCEDURE, WHEN STAPLING THE SKIN USING THE SKIN STAPLER AND STAPLES EXTRACTOR, THE SKIN STAPLES WERE NOT FIRM, AND THE SKIN WAS NOT CLOSED PROPERLY. ANOTHER SKIN STAPLER WAS USED TO RESOLVE THE ISSUE. AS A RESULT, THE OPERATION TIME WAS PROLONGED, AND THE PATIENT EXPERIENCED INCREASED PAIN.

  Patient problems: Pain

  MAUDE report 19195579 ↗
• InjuryApr 3, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Firing Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ACCORDING TO THE REPORTER, AT THE END OF CESAREAN SECTION, DURING SKIN CLOSURE, THERE WAS DIFFICULTY ATTACHING STAPLES. THE PATIENT HAD POST-OPERATIVE PAIN AND WAS REFERRED TO THE EMERGENCY ROOM FOR STAPLE REMOVAL. IT WAS NOTED THAT THEY HAD A HARD TIME REMOVING THE STAPLES. THE STAPLES WERE REMOVED USING A STAPLE EXTRACTOR WITH LOCAL ANESTHETIC.

  Patient problems: Pain

  MAUDE report 19033190 ↗
• InjuryApr 3, 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, AT THE END OF CESAREAN SECTION, DURING A SKIN CLOSURE, THERE WERE ISSUES WITH THE SKIN STAPLERS. THE PATIENT HAD POST-OPERATIVE PAIN AND WAS REFERRED TO THE EMERGENCY ROOM FOR STAPLE REMOVAL. IT WAS NOTED THAT THEY HAD A HARD TIME REMOVING THE STAPLES. THE STAPLES WERE REMOVED USING A STAPLE EXTRACTOR WITH LOCAL ANESTHETIC.

  Patient problems: Pain

  MAUDE report 19032897 ↗
• InjuryApr 3, 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, AT THE END OF CESAREAN SECTION, DURING A SKIN CLOSURE, THERE WERE ISSUES WITH THE SKIN STAPLERS. THE PATIENT HAD POST-OPERATIVE PAIN AND WAS REFERRED TO THE EMERGENCY ROOM FOR STAPLE REMOVAL. IT WAS NOTED THAT THEY HAD A HARD TIME REMOVING THE STAPLES. THE STAPLES WERE REMOVED USING A STAPLE EXTRACTOR WITH LOCAL ANESTHETIC.

  Patient problems: Pain

  MAUDE report 19032666 ↗