MAUDE Adverse Event Report: COVIDIEN ENDO STITCH AUTO SUTURE / ENDO SUTURING DEVICE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

Covidien endo stitch stopped functioning as the teal side handles became jammed not allowing the handles to return to the neutral position.Fda safety report id # (b)(4).

• Brand Name: ENDO STITCH AUTO SUTURE / ENDO SUTURING DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12313403
• MDR Text Key: 266480750
• Report Number: MW5103201
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J0J2750EY
• Was Device Available for Evaluation?: Yes
• 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 Age: 41 YR