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

Catalog Number 173016

Device Problems Break (1069); Difficult to Remove (1528); Misfire (2532)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2019

Event Type  malfunction  

Event Description

During procedure (hernia) after attempting to use the endo stitch suturing device with a needle, the device misfired and needle broke off.Attempts were made to remove, but were unsuccessful.Md did not feel additional procedure was warranted.

• Brand Name: ENDO STITCH SUTURING DEVICE
• Type of Device: "ENDOSCOPIC TISSUE APPROXIMATION DEVICE"
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8389802
• MDR Text Key: 137853025
• Report Number: MW5084624
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• 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: J8K033EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR