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

Model Number UNKNOWN ENDO STITCH SULU

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Unintended Radiation Exposure (4565)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

D10 concomitant product: unknown estitch, unknown endo stitch instrument (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 Description

According to the reporter, post operatively of a laparoscopic hysterectomy, the needle of the device came off midway suturing and had to be recovered.The needle was replaced to resolve the issue.However, 13 weeks post surgery the patient experienced vaginal cuff dehiscence.The patient experienced severe pain and had to have repair surgery in addition to having infection.A ct scan was done but the attending doctor noted that it did not show dehiscence; no physical examination was done.

• Brand Name: UNKNOWN ENDO STITCH SULU
• Type of Device: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18956145
• MDR Text Key: 338306368
• Report Number: 9612501-2024-00813
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO STITCH SULU
• Device Catalogue Number: UNKNOWN ENDO STITCH SULU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NOTE ON H11
• Patient Outcome(s): Other; Life Threatening; Required Intervention; Hospitalization