MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP II; CLIP, IMPLANTABLE

Model Number	176657
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 176657, 176657 endoclip ii ml 10 appli (lot # j5k3537ny); 176630, 176630 endoclip iii 5mm applier (lot # j6b4080y) 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 video-assisted thoracoscopic surgery (vats) lung resection procedure, the patient who had history of a sustained a stab wound that penetrated the lungs and required an exploratory procedure, experienced an issue in which the clips were loaded but would not close.It was further reported that a vessel rip/laceration occurred with profuse vessel bleeding, which was attributed to one of the clip appliers.Tissue damage was reported as a temporary injury.The bleeding was managed intraoperatively using an energy device (harmonic) to control the bleed.

• Brand Name: ENDO CLIP II
• Common Device Name: CLIP, IMPLANTABLE
• 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: 24991025
• Report Number: 9612501-2026-01158
• Device Sequence Number: 10295157
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: (01)10884521057869(17)300930(10)J5K2710NY
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143644
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J5K2710NY
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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 Sex: Unknown