MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	24055-
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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted a visual inspection of the returned photos noted: the first image depicts a white disengaged piece of seal being retrieved by an unknown grasping device during a surgical procedure.The second image depicts the tyvek product information label.The visual inspection of the returned products noted that there were no signs of particulate matter inside the package.The obturators, spiked trocars, circular seals and duckbill seals were intact.Functional testing proved the devices functioned normally.The tops were actuated and the flanges presented themselves cleanly locking into place.The tops were actuated in reverse and the flanges retracted perfectly.It was reported that 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 reported issue was confirmed.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medt ronic quality specifications.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): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23878418
• Report Number: 9612501-2025-03424
• Device Sequence Number: 9622930
• Product Code: GCJ
• UDI-Device Identifier: 10884521545137
• UDI-Public: (01)10884521545137(17)300531(10)J5F3460GY
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/25/2026

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: 24055-
• Device Catalogue Number: 24055-
• Device Lot Number: J5F3460GY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Patient Sex: Unknown