MAUDE Adverse Event Report: ETHICON VICRYL SUTURE 2.0

Catalog Number J417H

Device Problems Break (1069); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Type  No Answer Provided  

Event Description

During laparoscopic operation, a 2-0 vicryl suture broke in half.Both pieces of the needle were recovered from patient's abdomen in their entirety.

• Brand Name: VICRYL SUTURE 2.0
• Type of Device: VICRYL SUTURE 2.0
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6386818
• MDR Text Key: 69516165
• Report Number: MW5068320
• Device Sequence Number: 1
• Product Code: GAM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: J417H
• Device Lot Number: KM8060
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1