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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. VICRYL SUTURE, ABSORBABLE, SET

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ETHICON, INC. VICRYL SUTURE, ABSORBABLE, SET Back to Search Results
Model Number J603
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 08/21/2017
Event Type  malfunction  
Event Description
Surgical resident was inserting a "stay stitch" in umbilicus when the suture needle broke into two pieces leaving a half of the needle in the patient. The surgeon explored the surgical site and abdomen looking for the needle remnant and was unable to locate. X-ray was called to the or and the needle remnant was located and successfully removed from the patient. Packaging from broken suture saved.
 
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Brand NameVICRYL
Type of DeviceSUTURE, ABSORBABLE, SET
Manufacturer (Section D)
ETHICON, INC.
route 22 west
p.o. box 151
somerville NJ 08876
MDR Report Key6937118
MDR Text Key88864834
Report Number6937118
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/14/2017,09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJ603
Device Catalogue NumberJ603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/10/2017 Patient Sequence Number: 1
Treatment
N/A.
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