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

Model Number	8886803512
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: 8886803512, 8886803512 appose ulc 35 reg skin stap (lot j4m2562ly); 8886803512, 8886803512 appose ulc 35 reg skin stap (lot j4m2562ly); 8886803512, 8886803512 appose ulc 35 reg skin stap (lot j4m2562ly); 8886803512, 8886803512 appose ulc 35 reg skin stap (lot j4m2562ly).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
It was reported that during a bilateral arm lifts and bilateral thigh lifts procedure, in skin closure, the staple seems to deployed and one side of the stapler was in the edge of the skin and the other side was stacked or jammed in the device.The surgeon tried to fire it again to release the skin but the stapler keep jamming inside.The surgeon had to release the stapler from the skin with a mosquito clip while the skin was jammed in the tip of stapler, so the edge of the skin was slightly damage.This issue occurred on a total of five skin staplers.It was noted that the surgeon had to choose a ¿healthy¿( fresh) skin edge to apply new staplers.It was noted that the surgical time was extended for more than 30 minutes.
Additional Manufacturer Narrative
Additional information: d4(udi), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was tissue hang-up, the skin stapler instrument failed to fire, and the stapler became stuck.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic 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: 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: 22040827
• Report Number: 9612501-2025-01312
• Device Sequence Number: 15718539
• Product Code: GDT
• UDI-Device Identifier: 10884521104365
• UDI-Public: (01)10884521104365(17)291130(10)J4M2562LY
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 08/01/2025

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: 8886803512
• Device Catalogue Number: 8886803512
• Device Lot Number: J4M2562LY
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 44 YR
• Patient Sex: Female