MAUDE Adverse Event Report: COVIDIEN AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-T10BTNL
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: oms-t10btnl omst10btnl 10 blunt tip trocar w/o latex - (lot#p5h1149) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
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.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the main valve seal was disengaged.The trocar balloon, lock collar and converter doors were intact.A visual inspection of the returned photos noted: the first image depicts two balloons not inflated with the lock collar foam blood stained along side three disengaged main valve seals with a piece broken off of the bottom one.The second image depicts a close-up of the three disengaged main valve seals, the center of the middle one is broken off.The third image depicts three disengaged main valve seals with the center of the top one disengaged and not in view.The fourth image depicts three disengaged main valve seals with the proximal end of the balloon in view.Functional testing found that the lock collar moved up and down the cannula and securely locked in place.The converter doors moved properly and were fixed securely in place.The balloon was inflated using the returned syringe, no leaks detected however an odd shape was noted.It was reported that 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 reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when excessive force is applied during clinical application.The evaluation detected an unreported condition: of balloon irregular shape, improper positioning that has no relationship to the reported condition.The product analysis noted evidence that the device was not used as intended.This issue can occur when positioning the device during its inflation deployment or deflation process, or its tissue planes process, during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: damage to the balloon by instruments used during insertion and in the course of a procedure may cause device failure.Once the extraperitoneal space is adequately dissected, deflate the dissection balloon by removing the endoscope or by removing the inflation bulb from the dissector.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AUTO SUTURE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24849527
• Report Number: 2647580-2026-01021
• Device Sequence Number: 12993474
• Product Code: GCJ
• UDI-Device Identifier: 10884521527386
• UDI-Public: (01)10884521527386(17)280731(10)P5H1149(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K924011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OMS-T10BTNL
• Device Catalogue Number: OMS-T10BTNL
• Device Lot Number: P5H1149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 54 YR
• Patient Sex: Female