Auto Suture OMS-T10BTNLRecalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 10884521527386), received between Nov 7, 2016 and Apr 12, 2026 — classified as 2 injuries, 216 malfunctions.

The most frequently reported specific device problem is “Break” (110 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K924011); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Feb 28, 2024Class IIOpen, Classified

   The potential for trocar seal disengagement when using mesh products incorrectly with the device.

   Z-1466-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING RETRIEVAL OF THE SPECIMEN (GALLBLADDER) VIA PORT, THE GREY SILICON SEAL WAS DAMAGED AND BROKE OFF WHEN THE BAG WAS PUSHED INSIDE THE PORT. THE SEAL FELL INTO THE ABDOMEN AND IT WAS RETRIEVED BY THE SURGEON WITH A LAPAROSCOPIC INSTRUMENT. THE SAME ISSUE OCCURRED ON THE SECOND TROCAR. A THIRD TROCAR WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS ALREADY DISCHARGED FROM THE WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853107 ↗
• MalfunctionApr 11, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING RETRIEVAL OF THE SPECIMEN (GALLBLADDER) VIA PORT, THE GREY SILICON SEAL WAS DAMAGED AND BROKE OFF WHEN THE BAG WAS PUSHED INSIDE THE PORT. THE SEAL FELL INTO THE ABDOMEN AND IT WAS RETRIEVEDBY THE SURGEON WITH A LAPAROSCOPIC INSTRUMENT. THE SAME ISSUE OCCURRED ON THE SECOND TROCAR. A THIRD TROCAR WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS ALREADY DISCHARGED FROM THE WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849527 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC UROLOGICAL PROCEDURE, PART OF THE TROCAR RING WAS DETACHED DURING THE SURGERY. THE COMPONENT DID NOT FELL INTO THE PATIENT CAVITY. THE TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292731 ↗
• MalfunctionJan 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR WAS IN PLACE IN THE PATIENT¿S ABDOMEN. DURING MANIPULATION OF THE SCOPE WITHIN THE TROCAR, THE GREY PLASTIC TIP PUSHER BECAME DETACHED AND GOT STUCK BUT DID NOT FALL INTO THE CAVITY OF THE PATIENT. REMOVAL OF THE TROCAR, USE OF ANOTHER WAS DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053894 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE USING A BLUNT-TIP TROCAR, THE TOP PART OF THE DEVICE CAME APART INTO SMALL PIECES, AND A SMALL, ROUND SPRING FELL INSIDE THE PATIENT. THE VALVE SEAL DISENGAGED. THE INCIDENT OCCURRED WHEN THE OPTICS WERE INSERTED. THE SURGEON NOTICED THE ISSUE AND WAS ABLE TO REMOVE THE SPRING WITHOUT CAUSING HARM WITH THE USE OF LAPAROSCOPIC FORCEPS. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 10 MINUTES TO RESOLVE THE ISSUE, AND NO ADDITIONAL OPERATION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990944 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, DURING REMOVAL OF THE OPEN TROCAR, THE BALLOON DISENGAGED FROM THE TROCAR/SLEEVE AND REMAINED IN THE PATIENT'S ABDOMEN DESPITE THE SURGEON DEFLATING IT ACCORDING TO STATED INSTRUCTIONS. THE BALLOON, A DEVICE COMPONENT, FELL INTO THE CAVITY OF THE PATIENT. THE ISSUE WAS RESOLVED BY REMOVING THE BALLOON FROM THE PATIENT'S CAVITY WITH A LAPAROSCOPIC INSTRUMENT AND REPLACING IT WITH A NEW TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986619 ↗
• MalfunctionNov 6, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TROCAR VALVE REMAINED OPEN, CAUSING GAS TO LEAK INTO THE ABDOMINAL CAVITY. THIS REQUIRED AN INCREASE IN GAS FLOW, RESULTING IN EXCESSIVE CONSUMPTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485867 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY BROKE. THE BALLOON WAS PUNCTURED FROM THE START, AND THE TROCAR WAS CHANGED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285444 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE INSERTION OF THE BLUNT TIP TROCAR FOR LAPAROSCOPY, THE BALLOON RUPTURE OCCURRED WITH TWO DIFFERENT TROCARS FROM THE SAME BATCH, AND THE BALLOON PHYSICALLY BROKE. THE PRODUCT WAS REPLACED WITH ANOTHER BATCH AVAILABLE IN THE OPERATING ROOM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586350 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE INSERTION OF THE BLUNT TIP TROCAR FOR LAPAROSCOPY, THE BALLOON RUPTURE OCCURRED WITH TWO DIFFERENT TROCARS FROM THE SAME BATCH, AND THE BALLOON PHYSICALLY BROKE. THE PRODUCT WAS REPLACED WITH ANOTHER BATCH AVAILABLE IN THE OPERATING ROOM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586327 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS BEING USED TO ACCESS THE ABDOMINAL CAVITY WHEN THE BALLOON PHYSICALLY BROKE. THE SURGEON REPLACED THE TROCAR WITH A NEW ONE TO COMPLETE THE CASE. NO INJURY OR ADVERSE OUTCOME WAS REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248473 ↗
• MalfunctionApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE VALVE OF THE TROCAR DETACHED AND FELL INTO THE PATIENT'S CAVITY. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE AS IT WAS NECESSARY TO RETRIEVE THE PART FROM THE PATIENT. THE VALVE WAS RECOVERED AND NO OTHER COMPONENT LEFT INTO THE PATIENT. THE TROCAR WAS CHANGED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862327 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR PROCEDURE, WHEN PLACING THE MESH THROUGH THE TROCAR, THE VALVE SEAL BECAME DISLODGED. TO RESOLVE THE ISSUE, THE RUBBER SEAL WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124226 ↗
• MalfunctionDec 27, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA LAPAROSCOPY PROCEDURE, THE TROCAR WAS INVOLVED IN AN ISSUE WHERE THE BALLOON DID NOT INFLATE. THE LOT NUMBER OF THE DEVICE WAS KNOWN, AND IT WAS CONFIRMED THAT THIS WAS NOT A REPROCESSED SINGLE-USE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029189 ↗
• InjuryNov 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, 2 YEARS POST-OPERATIVE A LAPAROSCOPIC CHOLECYSTECTOMY, THE PATIENT WAS PRESENTED WITH PAIN OF THE LUMBER WALL. A CONTROL SCAN WAS PERFORMED AND THE FOREIGN BODY WAS FOUND THAT CORRESPONDS TO THE METAL PART PRESENT AT THE LEVEL OF THE TROCAR INLET VALVE, WHICH WOULD HAVE FALLEN OFF DURING THE EXTRACTION OF THE THREAD FROM THE BAG THAT COULD BE JETTISONED BY THE TROCAR. A SURGICAL EXTRACTION OF THE FOREIGN BODY WAS PERFORMED ON THE PATIENT.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 20761298 ↗
• MalfunctionNov 20, 2024Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE VALVE SEAL OF AN OMST10BTNL 10 BLUNT TIP TROCAR WITHOUT LATEX DISENGAGED, LEADING TO A RAPID LOSS OF ABDOMINAL PRESSURE AND LOSS OF PNEUMOPERITONEUM. THE ISSUE OCCURRED WHEN THE SURGEON WAS REMOVING THE TELESCOPE TO CLEAN IT, CAUSING THE VALVE IN THE PORT TO BECAME UNSTABLE. THE SURGEON RESOLVED THE ISSUE BY REMOVING THE TROCAR AND REPLACING IT WITH A BPT12STS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735930 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA REPAIR, THE SURGEON WAS INSERTING MESH THROUGH THE TROCAR WHEN THE VALVE SEAL INSIDE THE PATIENT DETACHED AND STUCK TO THE MESH. THE SURGEON WAS ABLE TO RETRIEVED IT WITH NO ISSUES. IT WAS ALSO NOTED THAT WHEN THE SURGEON WAS CLEANING THE SECOND TROCAR WITH A PORT CLEANER, THE TIP OF THE CLEANER GOT STUCK IN THE TROCAR. A NEW TROCAR WAS OPENED AND USED. THERE WAS NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621097 ↗
• MalfunctionNov 6, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA REPAIR, THE SURGEON WAS INSERTING MESH THROUGH THE TROCAR WHEN THE VALVE SEAL INSIDE THE PATIENT DETACHED AND STUCK TO THE MESH. THE SURGEON WAS ABLE TO RETRIEVED IT WITH NO ISSUES. IT WAS ALSO NOTED THAT WHEN THE SURGEON WAS CLEANING THE SECOND TROCAR WITH A PORT CLEANER, THE TIP OF THE CLEANER GOT STUCK IN THE TROCAR. A NEW TROCAR WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621063 ↗
• MalfunctionOct 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED TWICE IN A PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532684 ↗
• MalfunctionOct 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED TWICE IN A PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532640 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED THREE TIMES WITH ONE PATIENT AND TWICE WITH ANOTHER PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529568 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED THREE TIMES WITH ONE PATIENT AND TWICE WITH ANOTHER PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529001 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED THREE TIMES WITH ONE PATIENT AND TWICE WITH ANOTHER PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526863 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED THREE TIMES WITH ONE PATIENT AND TWICE WITH ANOTHER PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20526761 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON INSERTION AND INFLATION OF THE BALLOON, AFTER INSERTING THE TROCAR, THE BALLOON SHOULD BE INFLATED BUT THE AIR COULD NOT HOLD BECAUSE OF A HOLE IN THE BALLOON. IN ADDITION, THE BALLOON MOVED FROM THE TROCAR. THIS HAPPENED THREE TIMES WITH ONE PATIENT AND TWICE WITH ANOTHER PATIENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525663 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924011. One submission often covers many models, so check the product and lot details in each record.

• Z-1471-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
• Z-1468-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
• Z-1467-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
• Z-1465-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
• Z-1470-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
• Z-1469-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS