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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A SCALPEL, ULTRASONIC, REPROCESSED

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STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number N/A
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2017
Event Type  Malfunction  
Event Description

The harmonic device would only work periodically.

 
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Brand NameN/A
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS, INC.
1810 w. drake dr.
tempe AZ 85283
MDR Report Key6348677
MDR Text Key67946775
Report Number6348677
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/21/2017
Device MODEL NumberN/A
Device Catalogue NumberHAR36
Device LOT Number4965108
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2017
Event Location Hospital
Date Report TO Manufacturer02/20/2017
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? Yes
Type of Device Usage

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