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U.S. Department of Health and Human Services

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

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STRYKER SUSTAINABILITY SOLUTIONS; SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Model Number HAR36
Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2015
Event Type  malfunction  
Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for evaluation.Inspection of the returned device revealed evidence of 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 generator and passed the initial testing.The foot pedals and min button were able to activate the device, but the max button would not activate the device.The device was able to successfully activate with the foot pedals and min button, and at no time did the device fail to activate or stop working, produce an error code or emit any adverse noise.The membrane switch assembly (msa) was tested, and the max button failed.Inspection of the msa revealed signs of dried fluid in the handle and underneath the max button pad.The device was examined further and a build up of tissue/fluid was noticed along the rod.The rod was inspected for fractures, and none were found.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid to rise up the rod into the handle.The cause of tissue/fluid build up is damage to the distal gasket; action is being taken to address this issue.Tissue build up due to distal gasket damage can disrupt harmonic frequency and potentially reduce cutting ability; therefore, the reported complaint was confirmed.
 
Event Description
It was reported that the generator for the har36 ultrasonic scalpel displayed a reactivate error message.The device was retested numerous times but would not pass testing.There was no medical intervention or adverse consequences reported.Surgical delay was minimal to replace the device.The procedure was completed successfully.
 
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Brand Name
NA
Type of Device
SCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS
1810 w. drake drive
tempe AZ 85283
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 Key4940274
MDR Text Key22890311
Report Number0001056128-2015-00068
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 Nurse
Report Date 06/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2015
Device Model NumberHAR36
Device Catalogue NumberHAR36RR
Device Lot Number3332951
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2014
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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