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

Model Number 1 PDS*II UR-6

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

While attempting to close the mid-epigastrium, the ur-6 needle broke in half.The fragment of metal was not visible or palpable.Fluoroscopy of c-arm was brought into the room and under fluoroscopic guidance, the location of the needle was identified.After extensive exploration of the area, the needle was grasped with a kelly and removed from the abdomen.

• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6120515
• MDR Text Key: 60796375
• Report Number: 6120515
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: 1 PDS*II UR-6
• Device Catalogue Number: D9696
• Device Lot Number: KEZ097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2016
• 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
• Treatment: NO OTHER THERAPIES
• Patient Age: 31 YR
• Patient Weight: 77