MAUDE Adverse Event Report: ETHICON, INC. VICRYL; SUTURE, ABSORBABLE, SET

Model Number J603

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

Patient Problem No Code Available (3191)

Event Date 08/21/2017

Event Type  malfunction  

Event Description

Surgical resident was inserting a "stay stitch" in umbilicus when the suture needle broke into two pieces leaving a half of the needle in the patient.The surgeon explored the surgical site and abdomen looking for the needle remnant and was unable to locate.X-ray was called to the or and the needle remnant was located and successfully removed from the patient.Packaging from broken suture saved.

• Brand Name: VICRYL
• Type of Device: SUTURE, ABSORBABLE, SET
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6937118
• MDR Text Key: 88864834
• Report Number: 6937118
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017,09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J603
• Device Catalogue Number: J603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 21 YR