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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE
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ETHICON INC. PDSII VIO 27IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number Z341H
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/23/2019
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 an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, when closing a wound, the surgeon was pulling on the needle with the needle driver and the needle popped off the suture strand.It is unknown how the case was completed.No adverse patient consequences were reported.No additional information was provided.
 
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Brand Name
PDSII VIO 27IN 1 S/A CT-1
Common Device Name
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9368676
Report Number2210968-2019-90264
Device Sequence Number3042671
Product Code NEW
UDI-Device Identifier10705031060647
UDI-Public10705031060647
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
N18331
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) 11/06/2019
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 NumberZ341H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2019
Initial Report FDA Received Date11/25/2019
Patient Sequence Number1
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