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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 Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2015
Event Type  malfunction  
Event Description
It was reported that the har36 ultrasonic scalpel was making a funny noise.The device was stuttering during activation.There was no patient injury, medical intervention, adverse consequences, or surgical delay.The procedure was completed successfully.
 
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 an 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 a generator using the appropriate hand piece.The scalpel was tested and failed with two "tighten assembly" errors (after which the assembly was tightened) followed by 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 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/tissue to rise up the rod.The device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod.After further investigation completed on 5/27/2015 in a corrective and preventative action (capa) for tissue build up, the root cause of tissue/fluid build up was determined to be damage to the distal gasket.Corrective action has been taken to mitigate the occurrence of this issue.The reported event will continue to be monitored through post-market surveillance.
 
Manufacturer Narrative
Upon further review, it was determined that this report was out of scope of the two year reporting cycle that was initiated for distal gasket damage.
 
Event Description
It was reported that the har36 ultrasonic scalpel was making a funny noise.The device was stuttering during activation.There was no patient injury, medical intervention, adverse consequences, or surgical delay.The procedure was completed successfully.
 
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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 Key4870263
MDR Text Key5865617
Report Number0001056128-2015-00044
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 05/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
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 Number3369100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2014
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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