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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE Back to Search Results
Catalog Number SXPP1A419
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/20/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported that the patient underwent lap herniography on (b)(6) 2019 and suture was used.During the procedure, the suture detached at the swage point from the needle.The surgery was delayed five minutes due to the reported event.The procedure was successfully completed.There were no fragments generated.The procedure was completed with another device of the same product code.There were no patient consequences reported.
 
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Brand Name
STFX SYM PDS+ UNI VIO 9IN 2-0 S/A SH
Common Device Name
SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8701668
Report Number2210968-2019-82782
Device Sequence Number11254856
Product Code NEW
UDI-Device Identifier10705031245259
UDI-Public10705031245259
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K141776
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberSXPP1A419
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/14/2019
Patient Sequence Number1
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