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U.S. Department of Health and Human Services

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

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number HAR36
Device Problems False Alarm (1013); Loss of Power (1475); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2015
Event Type  Malfunction  
Manufacturer Narrative

The complaint device was returned to (b)(4) for evaluation. Inspection of the returned device revealed clinical use including biological material on the distal tip and indention in the teflon pad. The shaft rotation and the jaw actuation of the device were found to be acceptable. The device was connected to a generator and passed the initial testing. During testing on a test medium, various error messages were emitted by the generator. The device was examined further and a build up of tissue/fluid was noticed along the rod which can disrupt harmonic frequency and reduce cutting ability. The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod. The device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod. Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability. The reported event will continue to be monitored through post market surveillance.

 
Event Description

It was reported that har36 device had either intermittent signals, false alarms, or shut off. There was no patient injury or medical intervention, and extended procedure time reported was minimal.

 
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Brand NameNA
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key5109438
MDR Text Key27018584
Report Number0001056128-2015-00086
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK133672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device MODEL NumberHAR36
Device Catalogue NumberHAR36RR
Device LOT Number3782097
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

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