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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 HAR9F
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The device was inadvertently discarded.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The most likely root causes may be attributed to: too much force or torque applied to instrument, or grasping/pulling.Applying pressure between instrument blade and tissue pad without having tissue between them.Keeping clamp arm open when back cutting or while blade is active without tissue between blade and tissue pad.The instructions for use (ifu) state: 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 happens, there may be a system failure signaled by a continuous tone or alert screen when either of the foot pedals or hand control buttons is depressed.Keep the jaws of the device open when backcutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad and increased blade, clamp arm, and distal shaft temperatures.Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence or timing of the tone change.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.During and following activation in tissue, the instrument blade and clamp arm may become hot.Avoid unintended contact with tissue, drapes, surgical gowns, or other unintended sites at all times.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
 
Event Description
It was reported for a harmonic scalpel (har9f) that the teflon pad broke in half, specifically the top half/tip of the teflon pad.It fell off into patient but was retrieved immediately with a grasper.The device was replaced to successfully complete the procedure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
 
Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection of the device revealed evidence of clinical use.The blade and buttons appear to be intact.The teflon pad was slid towards the back of the clamp arm t-rail slot.Teflon pad t-rail was not lifted from the clamp arm.The teflon pad was intact but was not positioned correctly on the clamp arm.A nonconformance has been opened to address.The product problem of fully detached teflon pad reported in the executive summary was not confirmed upon investigation.The investigation results confirm this incident no longer falls within mdr reportability requirements.There was no patient injury and no history of injury from the failure mode of incorrectly positioned teflon pad in clamp arm.
 
Event Description
It was reported for a harmonic scalpel (har9f) that the teflon pad broke in half, specifically the top half/tip of the teflon pad.It fell off into patient but was retrieved immediately with a grasper.The device was replaced to successfully complete the procedure.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 Name
NA
Type of Device
SCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
MDR Report Key7627049
MDR Text Key112457653
Report Number0001056128-2018-00035
Device Sequence Number1
Product Code NLQ
UDI-Device Identifier07613327348248
UDI-Public07613327348248
Combination Product (y/n)N
PMA/PMN Number
K170456
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHAR9F
Device Catalogue NumberHAR9FRR
Device Lot Number7574178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Date Manufacturer Received07/03/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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