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U.S. Department of Health and Human Services

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

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ETHICON ACE HARMONIC SHEARS SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Catalog Number HAR36
Event Date 04/15/2016
Event Type  Malfunction  
Event Description

Ace harmonic tip melted during use. No pt harm.

 
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Brand NameETHICON ACE HARMONIC SHEARS
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300 region court
lakeland FL 33815
MDR Report Key5602941
Report Number5602941
Device Sequence Number1
Product CodeLFL
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device EXPIRATION Date03/03/2017
Device Catalogue NumberHAR36
Device LOT Number4412764
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2016
Event Location Hospital
Date Report TO Manufacturer04/20/2016
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/25/2016 Patient Sequence Number: 1
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