MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What is the product code and lot# of nylon suture? what layer of tissue was being used or closed? attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a gastric bypass procedure on (b)(6) 2018, suture was used. During the procedure, the needle pulled off the suture. There were no patient consequences reported. Additional information has been requested.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7259713
• MDR Text Key: 99988886
• Report Number: 2210968-2018-70771
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial