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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 Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2015
Event Type  malfunction  
Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for evaluation.The device was connected to scalpel generator, and failed with two "tighten assembly" errors (after which the assembly was tightened) and a "replace instrument" error.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 device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.
 
Event Description
It was reported that the har36 burned the bottom pad.There were no error messages on the generator.There was no patient injury, medical intervention, and extended procedure time reported was minimal.These are commonly used devices that are readily available.There is no history of injury from this reported event type.
 
Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed evidence of clinical use and an indention in the teflon pad.The scalpel was tested and failed with two "tighten assembly" errors (after which the assembly was tightened) and a "replace instrument" error.The device was disassembled, and the blade was inspected for cracks.A fracture was found in the blade.A review of the device history records supports that the device was unlikely to have been released from stryker with the reported failure mode.Therefore, the most likely root cause of the broken blade is incidental or prolonged activation against solid surfaces, such as bone, metal or plastic.The instructions for use state: "avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.".
 
Event Description
It was reported that the har36 burned the bottom pad.There were no error messages on the generator.There was no patient injury, medical intervention, and extended procedure time reported was minimal.These are commonly used devices that are readily available.There is no history of injury from this reported event type.
 
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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
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 Key5310642
MDR Text Key34616527
Report Number0001056128-2015-00122
Device Sequence Number1
Product Code NLQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133672
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,Followup
Report Date 10/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2016
Device Model NumberHAR36
Device Catalogue NumberHAR36RR
Device Lot Number3477845
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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