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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

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ETHICON INC. SUTURE UNKNOWN Back to Search Results
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.

 
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Brand NameSUTURE UNKNOWN
Type of DeviceSUTURE
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 Key7259713
MDR Text Key99988886
Report Number2210968-2018-70771
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberUNKNOWN
Number of Events Reported1
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 Received02/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
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

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