MAUDE Adverse Event Report: ETHICON ETHICON 4.0 VICRYL SUTURE

Model Number 4.0 COATED VICRYL

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/23/2016

Event Type  Injury  

Event Description

During laparoscopic abdominal surgery, while closing the sites, the tip of the suture needle broke off.Both pieces were recovered and an add'l package was opened and used.

• Brand Name: ETHICON 4.0 VICRYL SUTURE
• Type of Device: VICRYL SUTURE
• Manufacturer (Section D): ETHICON; somerville NJ 08876
• MDR Report Key: 5476581
• MDR Text Key: 39644223
• Report Number: MW5060690
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 4.0 COATED VICRYL
• Device Catalogue Number: J496 P34
• Device Lot Number: DL2422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR