MAUDE Adverse Event Report: COVIDIEN INC 0 SOFSILK SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number 170003

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Patient with a paraesophageal hernia had laparoscopic repair with nissen fundoplication.The hernia involved at least 50% of her stomach.During the fundoplication, the surgeon used three stitches of 0 silk on the endostitch device.Each stitch incorporated a bite of the left leaf of the wrap.During the first bite through the left leaf of the wrap, a needle on the endostitch broke in such a way that half of it remained within the endostitch device and the suture did not pass through the gastric wall.The other half of the needle was not retrieved.It was believed to be within the gastric wall.Efforts were made to find the 2 mm needle fragment, but it was not seen in the abdomen.Surgeon is aware and declined x-ray or further intervention to retrieve the fragment.Patient went to pacu in satisfactory condition and was discharged home the next day.Remainder of endostitch and needle was not saved.

• Brand Name: 0 SOFSILK SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN INC; 60 middletown ave; north haven CT 06473
• MDR Report Key: 4285943
• MDR Text Key: 5085456
• Report Number: 4285943
• Device Sequence Number: 2
• Product Code: GDW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/25/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 170003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2014
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 88