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

Model Number	173016
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: unk surgidac, sulu unknown, surgidac sulu, (lot#unknown).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
According to the reporter, during a laparoscopic nissen fundoplication, the needle was not on a secured locked position.The needle was loaded in device in the usual fashion and one stitch was placed after which it was noted the needle was rotated and was not allowing it to close properly and continue using the device to suture.The jaws did not close completely on the needle after the suture was passed through tissue and the provider was unable to shuttle the needle back and forth in the device.The surgeon closed the device as best as possible to remove the needle from patient.The device was removed and passed to the scrub nurse, where it was noted that there was no needle in the device or on the suture.There was no visualization of needle dropping in the peritoneal cavity.The device was only partially visualized during removal and was not visualized as it exited the port.It was noted that the location of needle was undetermined.The user looked in the peritoneal cavity and was unable to locate.Extensive search was done outside the patient and the user failed to locate the needle as well.The device was used approximately four more times without issue after the incident.

• 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: 24954676
• Report Number: 9612501-2026-01134
• Device Sequence Number: 13341106
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008(17)261130(10)J1M0009EY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: J1M0009EY
• 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: 04/08/2026
• Initial Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 12/01/2021
• 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: Life Threatening
• Patient Sex: Unknown