MAUDE Adverse Event Report: COVIDIEN LLC AUTO SUTURE; ENDO STITCH V-LOC 180

Catalog Number VLOCA208L

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2017

Event Type  malfunction  

Event Description

A (b)(6) -year-old female undergoing scheduled laparoscopic hysterectomy.During the cuff closure, in the lateral area near the thick uterosacral ligament, the endostitch device failed and the needle fractured.The 2mm tip was searched for but unable to be retrieved.The surgeon felt the risk was greater to continue to search than to leave the retained tip.

• Brand Name: AUTO SUTURE
• Type of Device: ENDO STITCH V-LOC 180
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6983165
• MDR Text Key: 90631858
• Report Number: MW5072977
• 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
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: VLOCA208L
• Device Lot Number: N7F1090X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 39 YR
• Patient Weight: 131