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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC HARMONIC ACE INSTRUMENT, ULTRASONIC

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STRYKER SUSTAINABILITY SOLUTIONS, INC HARMONIC ACE INSTRUMENT, ULTRASONIC Back to Search Results
Catalog Number HAR36
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem Test Result (2695)
Event Date 04/03/2015
Event Type  Malfunction  
Event Description

Tried to use the ace 36 harmonic and it kept resetting for no reason. Called clinical and they said disposable was not working right. Removed from service. ====================== manufacturer response for ace36 harmonic, (brand not provided) (per site reporter). ====================== rep was notified.

 
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Brand NameHARMONIC ACE
Type of DeviceINSTRUMENT, ULTRASONIC
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS, INC
5300 regions court
lakeland, FL 33815
MDR Report Key4705516
MDR Text Key18544851
Report Number4705516
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberHAR36
Device LOT Number3405718
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2015
Event Location Hospital
Date Report TO Manufacturer04/20/2015
Is this a Reprocessed and Reused Single-Use Device? Yes

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