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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 2-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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ETHICON INC. EB EXC GRN 36IN 2-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number X763H
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/17/2020
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) 2020; and a suture was used.During the procedure, the suture detached from the needle.The needle fell into the patient's body but was picked up immediately.It was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
EB EXC GRN 36IN 2-0 D/A SH-1
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10338132
Report Number2210968-2020-05660
Device Sequence Number3458354
Product Code GAT
UDI-Device Identifier10705031057944
UDI-Public10705031057944
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K946173
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/20/2020
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 Model NumberX763H
Device Catalogue NumberX763H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/20/2020
Initial Report FDA Received Date07/29/2020
Patient Sequence Number1
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