CAPSURE 0113215Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00801741094989), received between Mar 15, 2018 and Sep 8, 2026 — classified as 13 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670402 ↗
• MalfunctionJun 24, 2026Failure to Form Staple

  AS REPORTED, ON (B)(6) 2026 DURING A TAPP PROCEDURE USING CAPSURE STRAIGHT FIXATION DEVICE, NO RESISTANCE WAS FELT DURING THE FIRST FASTENER DEPLOYMENT, CAUSING THE FASTENERS TO SLIP OUT. THE DEVICE FUNCTIONED NORMALLY AFTER THE FIRST FIRE. REPORTEDLY, PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT ANY FURTHER COMPLICATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613904 ↗
• MalfunctionMay 1, 2026Material Twisted/Bent

  AS REPORTED, DURING A PROCEDURE THE ZIPPER (FASTENER) ON THE CAPSURE STRAIGHT WAS WARPED AND IT COULDN'T BE USED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055635 ↗
• MalfunctionApr 24, 2026Expulsion

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE USING CAPSURE ON A PATIENT, THE FASTENER PROTRUDED THROUGH THE SKIN. REPORTEDLY, THE PROTRUSION HAPPENED IMMEDIATELY AFTER THE FIXATION DURING THE PROCEDURE AND THE PENETRATED FASTENER PROBABLY LEFT IN PATIENT. IT IS BELIEVED THAT THE TIP OF THE FASTENER PROTRUDED SLIGHTLY BEYOND THE SKIN DUE TO THE PATIENT HAVING THIN SKIN (THIN BUILD) AND THE APPLICATION OF EXCESSIVE COUNTER PRESSURE DURING FIXATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983494 ↗
• MalfunctionMar 25, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC TAPP PROCEDURE, THE CAPSURE DEVICE TRIGGER FELT LOOSE AND DID NOT FIXATE THE FASTENERS PROPERLY. SOME FASTENERS WERE REPORTEDLY PLACED LOOSELY OR DISLODGED COMPLETELY, AND AFTER MULTIPLE TRIGGER PULLS, THE DEVICE BECAME JAMMED. THE LOOSE FASTENERS WERE RETRIEVED FROM THE PATIENT¿S BODY AND THE PROCEDURE WAS COMPLETED USING A NEW CAPSURE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686450 ↗
• MalfunctionMar 3, 2026Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE, TWO FASTENERS OF THE CAPSURE DEVICE CAME OUT SIMULTANEOUSLY DURING DRY FIRING. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500444 ↗
• MalfunctionFeb 25, 2026Unintended Ejection

  AS REPORTED, DURING A PROCEDURE USING CAPSURE FIXATION DEVICE, TWO FASTENERS WERE DEPLOYED IN A ROW. IT WAS REPORTED THAT TWO FASTENERS GOT FIXATED SUCCESSFULLY AND THE LOOSE FASTENERS WERE REMOVED FROM PATIENT'S BODY. THE FIXATION WAS APPLIED INTO A HARD STRUCTURE/BONE/COOPER¿S LIGAMENT ALSO THE SURGEON HAS PERFORMED DRY FIRE TO CHECK IF THE PROBLEM RE-OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446080 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE USING CAPSURE FIXATION DEVICE DURING FIXATION, THE FIRST FASTENER WAS DEPLOYED WITHOUT THE FASTENER CAP OBSERVED AND FURTHERMORE, WHEN THE TRIGGER WAS PULLED, NO FASTENER WAS EJECTED. REPORTEDLY, THE FASTENERS WERE NOT FIXED TO A RIGID STRUCTURE/BONE/COOPER'S LIGAMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364811 ↗
• MalfunctionDec 23, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, CAPSURE FIXATION DEVICE FAILED TO FIXATE. THREE FASTENERS WHICH WERE RELEASED FROM THE DEVICE WERE DIFFICULT TO INSERT AND DID NOT PENETRATE THE TISSUE DEEPLY, LEAVING A GAP BETWEEN THE MESH AND ABDOMINAL WALL. IT WAS REPORTED THAT THE THREE FASTENERS THAT DID NOT PENETRATE COMPLETELY WERE LEFT IN THE PATIENT'S BODY. ANOTHER CAPSURE DEVICE WAS THEN USED ALLOWING THE PROCEDURE TO FINISH WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877558 ↗
• MalfunctionDec 16, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, A LAPAROSCOPIC INGUINAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2025 USING A CAPSURE FIXATION DEVICE. DURING THIS PROCEDURE, THE FASTENERS FAILED TO FIXATE AND FELL INTO THE SURGICAL FIELD. IT WAS THEN REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817654 ↗
• MalfunctionDec 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING THE PROCEDURE, UPON OPENING THE PACKAGE, A "WHITE FOREIGN SUBSTANCE" WAS OBSERVED ON THE HANDLE OF THE CAPSURE FIXATION DEVICE. CONSEQUENTLY, THE PRODUCT WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THE PRODUCT BOX WAS FULLY SEALED PRIOR TO OPENING, AND THERE WAS NO PATIENT CONTACT WITH THE AFFECTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769138 ↗
• MalfunctionDec 1, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED CAPSURE FIXATION DEVICE WAS USED DURING THE TAPP PROCEDURES. THE INITIAL FASTENER FAILED TO FIXATE AND SLIPPED OFF THE TIP WHILE OPERATING THE DEVICE. IT WAS REPORTED THAT THE FIRST FASTENER HAS BEEN RETRIEVED. SUBSEQUENTLY, ALL THE REMAINING FASTENERS WERE FIXATED WITHOUT ANY ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680367 ↗
• MalfunctionNov 20, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED CAPSURE FIXATION DEVICE WAS USED DURING THE TAPP PROCEDURES. THE INITIAL FASTENER FAILED TO FIXATE AND SLIPPED OFF THE TIP WHILE OPERATING THE DEVICE. IT WAS REPORTED THAT THE FIRST FASTENER HAS BEEN RETRIEVED. SUBSEQUENTLY, ALL THE REMAINING FASTENERS WERE FIXATED WITHOUT ANY ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607601 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON OPENING THE PACKAGE INSIDE THE OPERATING ROOM, A LOOSE SCREW OF THE CAPSURE FIXATION DEVICE WAS OBSERVED. IT WAS REPORTED THAT THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485569 ↗
• MalfunctionOct 16, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE, WHEN FIXATING HARD TISSUE USING CAPSURE FIXATION DEVICE, THE FASTENER DID NOT EJECT. WHEN THE TRIGGER IS SUBSEQUENTLY PULLED, TWO FASTENERS WERE EJECTED IN A ROW. IT WAS REPORTED THAT THE LOOSE FASTENERS WERE REMOVED FROM PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312582 ↗
• MalfunctionOct 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, BEFORE OPENING A RED STAIN LIKE SUBSTANCE WAS NOTED INSIDE THE STERILE PACKAGING OF THE CAPSURE FIXATION DEVICE. IT WAS REPORTED THAT THE DEVICE WAS NOT OPENED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247884 ↗
• MalfunctionOct 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WHILE OPENING THE STERILE PACKAGE OF CAPSURE FIXATION DEVICE A CHUNK OF VINYL (LIKE A CHUNK OF CELLOPHANE TAPE) WAS OBSERVED. THE PRODUCT BOX WAS CONFIRMED TO BE FULLY SEALED WITH NO VISIBLE DAMAGE TO THE INNER OR OUTER PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210064 ↗
• MalfunctionAug 22, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING TAPP TECHNIQUE THE CAPSURE FIXATION DEVICE WAS USED TO FIXATE THE 3DMAX MESH. HOWEVER, THE DEPLOYED FASTENERS COULD NOT FIXATE THE MESH. IT WAS NOTED THAT FOLLOWING FIXATION TO COOPER¿S LIGAMENT, THE IMPACT FELT UNUSUAL. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO FIXATE THE MESH TO SOFT TISSUE, BUT THIS WAS UNSUCCESSFUL, AND A FASTENER FELL INTO THE ABDOMINAL CAVITY. THE FALLEN FASTENER WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22875945 ↗
• MalfunctionAug 22, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, A CAPSURE DEVICE WAS USED FOR FIXATION. AFTER SUCCESSFULLY FIRING THREE FASTENERS, A MISFIRE OCCURRED AND FOLLOWING THAT, TWO FASTENERS WERE DISCHARGED SIMULTANEOUSLY. SUBSEQUENTLY, THE TRIGGER BECAME STIFF, AND THE STAINLESS STEEL PART OF THE FASTENER WAS BENT UPON DISCHARGE. AS REPORTED, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT FIXATION WAS NOT APPLIED TO HARD STRUCTURE/BONE/COOPER¿S LIGAMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874106 ↗
• MalfunctionJul 31, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING MESH FIXATION, THE CAPSURE STRAIGHT FIXATION DEVICE DEPLOYED TWO FASTENERS AT THE SAME TIME DURING THE INITIAL SHOT. CONSEQUENTLY, BOTH THE FASTENERS THAT FELL INTO THE SURGICAL SITE WERE REMOVED AND IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675268 ↗
• MalfunctionJul 23, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING TAPP PROCEDURE, WHEN THE SURGEON WAS TRYING TO FIXATE IN THE PATIENT'S ABDOMEN WHEN TWO FASTENERS DEPLOYED DURING THE THIRD ATTEMPT WERE NOT FIXATED AND WERE FIRED IN VITRO. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576039 ↗
• MalfunctionJul 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A LAPAROSCOPIC HERNIA REPAIR, A COTTON LIKE FOREIGN MATERIAL WAS NOTED TO BE PRESENT WITHIN THE STERILE PACKAGE OF CAPSURE FIXATION DEVICE AND IT WAS NOT USED. IT WAS REPORTED THAT THE OPERATION WAS CARRIED OUT SUCCESSFULLY USING A DIFFERENT PRODUCT. PER INFORMATION PROVIDED, THERE WAS NO DAMAGE TO THE EXTERIOR AND THE SAMPLE WILL BE RETURNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519779 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE CAPSURE FIXATION DEVICE WAS USED TO FIXATE THE 3DMAX LIGHT MESH. WHEN FIXATING THE MESH, THE PEEK PART OF A FASTENER DETACHED, AND THE STEEL PART FIXATED THE MESH. IT WAS REPORTED THAT THE FIXATION WAS NOT APPLIED IN THE HARD STRUCTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350628 ↗
• MalfunctionJun 24, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE THE CAPSURE DEVICE DEPLOYED FIVE FASTENERS WHICH WERE SUCCESSFULLY FIXATED AND WHILE ATTEMPTING TO FIXATE THE NEXT FASTENER AT THE COOPER'S LIGAMENT, TWO FASTENERS WERE FIRED SIMULTANEOUSLY. THE SIXTH FASTENER WAS SECURED IN PLACE SUCCESSFULLY, AND THE SEVENTH FASTENER WAS ATTACHED TO THE SIXTH FASTENER AND COULD BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319165 ↗
• MalfunctionJun 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WHEN THE PHYSICIAN OPENED THE PACKAGE TO USE THE CAPSURE DEVICE, THEY FOUND SOME DEBRIS INSIDE. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE PRODUCT ITSELF, AND THE DEVICE WAS USED AND COMPLETED THE SURGERY WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296499 ↗