MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	173016
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a laparoscopic duodenal switch, while approximating the small bowel, the surgeon had completed the use of the suture, the device worked completely fine.Once the surgeon had cut the suture to take the endostitch device out of the abdomen, the needle had fallen lose and it was lost in the operating room.The c-arm was brought into the room to see if the needle could be found inside the patient¿s abdomen, but the result came back negative.The surgical time was extended by more than 30 minutes.The endostitch device was used again with no issue, but the needle was unable to be found.
Additional Manufacturer Narrative
D10 concomitant products: vloca206l, vloca206l v-loc* 180 2-0 abs reload15cm - (lot#: n4d2362y).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: ENDO STITCH
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• 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: 25559904
• Report Number: 9612501-2026-01675
• Device Sequence Number: 10213468
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008(17)301130(10)J5M2752EY
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J5M2752EY
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 12/13/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male