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U.S. Department of Health and Human Services

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

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ETHICON HARMONIC ACE SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Catalog Number HAR 36
Event Date 01/19/2016
Event Type  Malfunction  
Event Description

Plastic from harmonic handpiece fell off during procedure into patient. It was retrieved from patient without incident, a larger incision was not necessary.

 
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Brand NameETHICON HARMONIC ACE
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300 region drive
lakeland FL 33815
MDR Report Key5496626
Report Number5496626
Device Sequence Number1
Product CodeLFL
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/28/2016,03/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device EXPIRATION Date10/16/2016
Device Catalogue NumberHAR 36
Device LOT Number4010391
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2016
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer01/28/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/14/2016 Patient Sequence Number: 1
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