MAUDE Adverse Event Report: COVIDIEN ENDO STITCH AUTO SUTURING DEVICE

Model Number #173016

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2017

Event Type  Injury  

Event Description

V-loc stitch came off suture during the procedure.This was immediately realized at the time of the event.A single view pelvic x-ray was taken to confirm the placement of the needle in the patient.A needle fragment was recovered and not the whole needle.(b)(4), sales rep with medtronic, in possession of the single use device.

• Brand Name: ENDO STITCH AUTO SUTURING DEVICE
• Type of Device: ENDO STITCH AUTO SUTURING DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6673111
• MDR Text Key: 78696912
• Report Number: MW5070672
• Device Sequence Number: 1
• Product Code: MFJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: #173016
• Device Lot Number: J7B1516X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 121