Auto Suture 24055Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10884521545137), received between Nov 16, 2017 and Sep 30, 2026 — classified as 8 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (93 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  It was reported that during a laparoscopic hysterectomy, two trocars had a damaged seal. Part of the plastic opening inside the port fell into the patient¿s cavity. Several minutes of medical or surgical intervention were needed to prevent permanent impairment of function, and another trocar was opened to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941666 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936626 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VAGINAL HYSTERECTOMY PROCEDURE, DEBRIS FROM THE TROCAR WAS FOUND IN THE PATIENT'S ABDOMEN. THIS ISSUE RESULTED IN AN EXTENDED SURGICAL TIME BY LESS THAN 30 MINUTES, AS THE SURGEON HAD TO RECOVER THE DEBRIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129445 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORT FROM THERAPEUTIC GOODS ADMINISTRATION (TGA), DURING A LAPAROSCOPIC SURGERY, THE LAPAROSCOPIC FORCEPS WAS INSERTED INTO THE PORT (FIRST ENTRY) SOME RUBBER MATERIAL BROKE OFF INTO THE PATIENT. THE MATERIAL WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 25126117 ↗
• InjuryMar 30, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, DURING INSERTION OF THE PORTS, IT WAS FOUND THAT MULTIPLE WHITE PIECES FELL INTO THE PATIENT. THESE WHITE COMPONENTS WERE PARTS OF THE PORT SEAL THAT HAD BEEN SHAVED OFF BY THE BLADE OBTURATOR. TWO WHITE COMPONENTS WERE RETRIEVED USING REUSABLE LAPAROSCOPIC GRASPERS, WHILE ONE COMPONENT COULD NOT BE RETRIEVED AS IT BECAME TRAPPED UNDER THE MESH INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24726637 ↗
• InjuryMar 30, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, DURING INSERTION OF THE PORTS, IT WAS FOUND THAT MULTIPLE WHITE PIECES FELL INTO THE PATIENT. THESE WHITE COMPONENTS WERE PARTS OF THE PORT SEAL THAT HAD BEEN SHAVED OFF BY THE BLADE OBTURATOR. TWO WHITE COMPONENTS WERE RETRIEVED USING REUSABLE LAPAROSCOPIC GRASPERS, WHILE ONE COMPONENT COULD NOT BE RETRIEVED AS IT BECAME TRAPPED UNDER THE MESH INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24726510 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, IT WAS NOTICED THAT A SMALL WHITE COMPONENT, ASSUMED TO BE A PORTION OF THE DAMAGED SEAL SHAVED OFF BY THE BLADE OBTURATOR, FELL INTO THE PATIENT UPON INSERTION OF THE PORT. IT WAS ATTEMPTED TO BE RETRIEVED WITH SURGICAL GRASPERS, BUT UPON REMOVING THE COMPONENT FROM THE PATIENT THROUGH THE PORT, IT COULD NOT BE FOUND IN THE GRASPERS OUTSIDE THE BODY. THE LOCATION OF THE PIECE IS UNKNOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672115 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE SEAL OF THE DEVICE WAS DAMAGED WHEN THE SURGEON PASSED THROUGH AN ENDOLOOP. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573259 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SALPINGECTOMY, A SMALL PIECE OF PLASTIC FELL FROM THE MANDREL (LODGED BETWEEN THE DISTAL END AND THE ALUMINUM). IT OCCURRED ON TWO DEVICES. THE SAME WHITE FRAGMENTS WERE RETRIEVED EXCEPT FOR ONE THAT COULD NOT FIND IN THE PATIENT'S CAVITY. IT WAS NOTED THAT THE OBTURATOR CUTS THE RING UPON INSERTION. ANOTHER LOT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24369199 ↗
• MalfunctionFeb 6, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE OBTURATOR BROKE WHEN A PORTION OF THE WHITE PLASTIC STYLET WAS CUT BY THE KNIFE BLADE DURING INTRODUCTION OF THE TROCAR IN THE ABDOMEN. A PORTION OF THE WHITE PLASTIC STYLET FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON USED A GRASPER TO RETRIEVE THE PLASTIC PIECE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281571 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SURGICAL PROCEDURE INVOLVING THE USE OF A PORT, A SMALL PIECE OF MATERIAL BROKE OFF UPON PORT INSERTION AND ENTERED THE PATIENT¿S ABDOMINAL CAVITY, THE FRAGMENT, DESCRIBED AS AN ADHESIVE OR RUBBERY SUBSTANCE MEASURING APPROXIMATELY 5¿7 MM, WAS IDENTIFIED AND SUCCESSFULLY REMOVED BY THE SURGEON INTRAOPERATIVELY. THE ISSUE WAS RESOLVED AT THE TIME OF THE PROCEDURE WITH REMOVAL OF THE FOREIGN MATERIAL, AND NO ADDITIONAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24220101 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, THE DEVICE EXHIBITED A DAMAGED SEAL, A DISENGAGED SEAL, AN D A PIECE OF PLASTIC WAS OBSERVED HANGING IN THE TROCAR SLEEVE DURING INSERTION. ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191275 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON INSERTION OF INSTRUMENT INTO THE PORT, A SMALL SEGMENT OF RUBBER WAS PUNCHED OUT INTO THE ABDOMINAL CAVITY AND WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 24125869 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON INSERTION OF INSTRUMENT INTO THE PORT, A SMALL SEGMENT OF RUBBER WAS PUNCHED OUT INTO THE ABDOMINAL CAVITY AND WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 24118370 ↗
• MalfunctionJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, GREY PART OF THE TROCAR BROKE OFF AND POPPED OUT OF THE END OF THE DEVICE WHEN AN INSTRUMENT WAS INSERTED. THE GREY PIECE WAS FOUND IN THE ABDOMEN OF THE PATIENT AND WAS RETRIEVED WITH A LAPAROSCOPIC GRIPPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078319 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE INVOLVING THE ACCESS PORT, A GREY PART OF THE DEVICE BROKE OFF AND POPPED OUT OF THE END OF THE TROCAR WHEN AN INSTRUMENT WAS INSERTED. THE GREY PIECE WAS FOUND IN THE ABDOMEN OF THE PATIENT AND WAS RETRIEVED WITH A LAPAROSCOPIC GRIPPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064325 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SALPINGECTOMY, A GREY COMPONENT WAS NOTICED AT THE END OF THE TROCAR AS SOON AS THE MANDREL WAS INSERTED INTO IT, EVEN BEFORE THE START OF THE SURGERY. THE GRAY COMPONENT WAS RETRIEVED AND THE TROCAR WAS CHANGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051280 ↗
• MalfunctionJan 7, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE CANNULA BROKE DURING INSTRUMENT REMOVAL. THE DEBRIS WAS OBSERVED DETACHING AND WAS RETRIEVED FROM THE ABDOMEN USING A SUCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989224 ↗
• MalfunctionJan 7, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE CANNULA BROKE DURING INSTRUMENT REMOVAL. THE DEBRIS WAS OBSERVED DETACHING AND WAS RETRIEVED FROM THE ABDOMEN USING A SUCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989105 ↗
• MalfunctionJan 7, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE CANNULA BROKE DURING INSTRUMENT REMOVAL. THE DEBRIS WAS OBSERVED DETACHING AND WAS RETRIEVED FROM THE ABDOMEN USING A SUCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989043 ↗
• MalfunctionJan 7, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE CANNULA BROKE DURING INSTRUMENT REMOVAL. THE DEBRIS WAS OBSERVED DETACHING AND WAS RETRIEVED FROM THE ABDOMEN USING A SUCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988956 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THE SEAL OF THE DEVICE WAS DAMAGED AND A SMALL COMPONENT OF THE SEAL WAS SHAVED OFF BY THE BLADED OBTURATOR. THIS SMALL COMPONENT OF THE SEAL FELL INTO THE PATIENT DURING DEVICE INSERTION THROUGH THE ABDOMINAL WALL. THE COMPONENT WAS RETRIEVED FROM THE PATIENT USING REUSABLE LAPAROSCOPIC GRASPERS. THE CASE WAS COMPLETED AFTER RETRIEVAL OF THE SEAL COMPONENT, AND NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878418 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY, DURING THE RETRIEVAL OF THE LOCKING TROCAR, TWO PIECES OF PLASTIC OF THE LOCKING DEVICE DETACHED FROM THE TROCAR AND FELL INTO THE ABDOMEN. THE SURGEON USED A GRASPER TO RETRIEVE THE TWO PLASTIC PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871124 ↗
• MalfunctionDec 18, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, ON INSERTION OF AN INSTRUMENT INTO THE PORT A SMALL SEGMENT OF RUBBER WAS PUNCHED OUT INTO THE ABDOMINAL CAVITY. IT THEN WAS REMOVED WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846215 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HERNIA, WHILE GAINING ACCESS, PLASTIC PIECES OF THE VALVES OF FOUR PORTS BROKE AND FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON REMOVED THE PIECES OF PLASTIC WHEN THEY COULD BE FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825404 ↗