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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 Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, an indentation in the teflon pad and evidence of clinical use was identified. A review of the device history record indicates the device met all inspection and test criteria prior to release. The most likely root cause is excessive contamination under the msa (membrane switch assembly) max button cover due to fluid ingress through the handle assembly. This is most likely attributed to: - inadequate cleaning of the device during operation. Operating technique of the device. The instructions for use (ifu) state: "attach the hand piece to the instrument by rotating the instrument onto the hand piece in a clockwise rotation as viewed from the distal end of the instrument (finger tight only). " "use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece. Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade. " "blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft. To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft. " "for optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline. " "if tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece. If desired, the instrument may be unplugged. " ¿care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them. Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument. If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message. " the reported event will continue to be monitored through post market surveillance.

 
Event Description

It was reported after about five hours, the surgeon had difficulty with the device working intermittently. There was no patient injury, medical intervention, and extended procedure time reported was minimal. These are commonly used devices that are readily available.

 
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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 Key5626019
MDR Text Key44805798
Report Number0001056128-2016-00053
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeUS
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 03/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/06/2017
Device MODEL NumberHAR36
Device Catalogue NumberHAR36RR
Device LOT Number4275745
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/23/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/20/2016
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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