MAUDE Adverse Event Report: ETHICON, INC. VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number #3-0

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/11/2016

Event Type  malfunction  

Event Description

A #3-0 vicryl needle broke off inside patient's rectum during procedure to repair rectal prolapse.The needle broke off in the bowel tissue.The physician was able to retrieve the broken piece.This delayed the case for some time.No further action needed.We don't have the package for the needle.

• Brand Name: VICRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, INC.; route 22 west; po box 151; somerville, NJ 08876
• MDR Report Key: 5808216
• MDR Text Key: 49965446
• Report Number: 5808216
• Device Sequence Number: 1
• Product Code: GAM
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: #3-0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• 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
• Patient Age: 67 YR