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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 Problems Device Operates Differently Than Expected (2913); Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2017
Event Type  Malfunction  
Event Description

The reprocessed shears caused a problem with the generator which required manual reset very often during the procedure. This usually happens when the shears are being applied to an area of bleeding tissue when cautery energy is most needed. Harmonic ace shears were replaced with the advanced hemostasis which performed without issue for the remainder of the case.

 
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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 Key6328408
MDR Text Key67566835
Report Number6328408
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 01/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue NumberHAR36
Device LOT Number5449203
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2017
Event Location Hospital
Date Report TO Manufacturer01/25/2017
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?
Type of Device Usage

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