MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD APPOSE ULC; STAPLE, REMOVABLE (SKIN)

Model Number	8886803712
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Align (2522)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a skin closure, at the time of stapling, the staple remained stuck on the patient's scalp.There was difficulty for the surgeon to get it off, and the staples appeared to be poorly positioned in the skin stapler.Another skin stapler from a different batch presented the same issue.The surgeon removed the staple from the wound and sutured it in place.Surgical time was extended for less than 30 minutes.
Additional Manufacturer Narrative
D10 concomitant medical products: 8886803712 8886803712 appose ulc 35 wide skin stap - (lot#j4l2373ly) 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: APPOSE ULC
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21527168
• Report Number: 9612501-2025-00658
• Device Sequence Number: 9696423
• Product Code: GDT
• UDI-Device Identifier: 10884521104372
• UDI-Public: 10884521104372
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K900486
• 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
• Report Date (Section B): 03/05/2025

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: 8886803712
• Device Catalogue Number: 8886803712
• Device Lot Number: J4B3494LY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 02/20/2024
• 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