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U.S. Department of Health and Human Services

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

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ETHICON HARMONIC ACE SHEARS . SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number HAR36
Event Date 03/20/2015
Event Type  Malfunction  
Event Description

When first plugging the shears into machine, the words 'test failure' appeared and the device would not work.

 
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Brand NameETHICON HARMONIC ACE SHEARS .
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300 regions court
lakeland FL 33815
MDR Report Key4686890
Report Number4686890
Device Sequence Number1
Product CodeNLQ
Report Source User Facility
Type of Report Initial
Report Date 03/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL NumberHAR36
Device Catalogue NumberHAR36
Device LOT Number3408903
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/27/2015
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2015
Event Location Hospital
Date Report TO Manufacturer04/14/2015
Is this a Reprocessed and Reused Single-Use Device? Yes

Patient TREATMENT DATA
Date Received: 04/02/2015 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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