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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 05/27/2019
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 a patient underwent a laparoscopic robotic hernia repair on (b)(6) 2019 and a barbed suture was used.During the procedure, the suture separated from the needle.It is unknown whether a similar device was used to complete the procedure, which was done successfully.There were no adverse patient consequences.No additional information was provided.
 
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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 Key8731321
Report Number2210968-2019-83250
Device Sequence Number2004369
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) 05/31/2019
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 05/31/2019
Initial Report FDA Received Date06/25/2019
Patient Sequence Number1
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