MAUDE Adverse Event Report: ETHICON, INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPD1B400

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 01/30/2014

Event Type  No Answer Provided  

Event Description

During laparoscopic uterine myomectomy, the uterus was sutured with stratafix.The scrub tech noted that the tip of one of the stratafix ct-1 needles was missing.Attempts to locate it were unsuccessful and a postoperative abdominal x-ray was performed, which revealed no radiopaque foreign body.

• Brand Name: STRATAFIX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p o box 151; somerville NJ 08876
• MDR Report Key: 3608711
• MDR Text Key: 15808875
• Report Number: 3608711
• Device Sequence Number: 1
• Product Code: NEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Catalogue Number: SXPD1B400
• Device Lot Number: MBYS210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR