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

Catalog Number 173016

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

Endo stitch malfunctioned.New one opened.Fda safety report id# (b)(4).

• Brand Name: ENDO STITCH SUTURING DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12254109
• MDR Text Key: 264544161
• Report Number: MW5102885
• Device Sequence Number: 1
• Product Code: OCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 173016
• Device Lot Number: J0L2591EY
• 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: 80 YR
• Patient Weight: 56