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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 Consequences Or Impact To Patient (2199)
Event Date 05/11/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, evidence of clinical use and an indention on the teflon pad was identified. The distal gasket was examined and tissue/fluid build up was identified proximal to the distal gasket. The distal gasket appeared to be worn out and showed signs of minimal damage. A review of the dhr supports that the device met all inspection and test criteria prior to release. The most likely root cause of tissue/fluid buildup is damage to the distal gasket. As the causes of distal gasket damage are undetermined at this time; preventative measures have been taken to prevent the escape of any product exhibiting this failure mode. Therefore, the potential root cause is damage to the distal gasket subsequent to distribution at customer site. The instructions for use (ifu) state: "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 instruments allow for the coagulation of vessels up to and including 5mm in diameter. Do not attempt to seal vessels in excess of 5mm in diameter. " "select the desired minimum power level using the increase and decrease buttons on the generator touchscreen. Note: the recommended minimum starting power level is level 3. For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level. The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type pathology, and surgical technique. " the reported event will continue to be monitored through post-market surveillance.

 
Event Description

It was reported the harmonic scalpel was working intermittently. There was no patient injury, medical intervention, or extended procedure time reported. 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 Key5737126
MDR Text Key48724244
Report Number0001056128-2016-00080
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 05/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2016
Device MODEL NumberHAR36
Device Catalogue NumberHAR36RR
Device LOT Number4062099
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2015
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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