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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. ETHICON SECURESTRAP STAPLE, IMPLANTABLE

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ETHICON, INC. ETHICON SECURESTRAP STAPLE, IMPLANTABLE Back to Search Results
Catalog Number STRAP25
Event Date 03/03/2016
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

Ethicon securestrap- 2 devices malfunctioned. One device fired numerous blank straps without device indicator turning orange (lot jlk983). Second device fired approximately 10 straps and the rest were blank - the indicator did turn orange after the approx. 10 straps were fired (lot jlm634).

 
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Brand NameETHICON SECURESTRAP
Type of DeviceSTAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON, INC.
rout 22 west
somerville NJ 08876
MDR Report Key5494557
Report Number5494557
Device Sequence Number1
Product CodeGDW
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberSTRAP25
Device LOT NumberJLK983
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2016
Event Location Hospital
Date Report TO Manufacturer03/03/2016
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: 03/11/2016 Patient Sequence Number: 1
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