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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. ETHICON HARMONIC ACE SHEARS SCALPEL, ULTRASONIC, REPROCESSED

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STRYKER SUSTAINABILITY SOLUTIONS, INC. ETHICON HARMONIC ACE SHEARS SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number 5MM DIAMETER 36 CM LENGTH
Event Date 02/03/2015
Event Type  Malfunction  
Event Description

Shears were not sealing, made a sizzling sound and sparked. Caused patient to have uncontrollable bleeding. Had to get another hand piece to stop bleeding and put in a stitch.

 
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Brand NameETHICON HARMONIC ACE SHEARS
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS, INC.
1810 w. drake dr.
tempe AZ 85283
MDR Report Key4510148
Report Number4510148
Device Sequence Number1
Product CodeNLQ
Report Source User Facility
Type of Report Initial
Report Date 02/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device MODEL Number5MM DIAMETER 36 CM LENGTH
Device Catalogue NumberHAR36
Device LOT Number3329487
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2015
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2015
Event Location Hospital
Date Report TO Manufacturer02/12/2015
Is this a Reprocessed and Reused Single-Use Device? Yes

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