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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 Problems Premature Elective Replacement Indicator (1483); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the received complaint device, an indentation in the teflon pad and evidence of clinical use including tissue build up was identified. The device was disassembled to inspect the blade rod and distal gasket. The distal gasket on the rod was examined and revealed no damage. The blade was cleaned then inspected and gouges and a fracture were found on the distal blade. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. Therefore, the most likely root causes are: - jaws/blade subassembly damage - incidental and prolonged activation against solid surfaces, such as bone, metal or plastic the instructions for use (ifu) 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. - use the torque wrench (already mounted to the shaft) to tighten the blade on the hand piece. Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating the sufficient torque has been applied to secure the blade. Note: do not use any other means that the torque wrench to attach or detach the instrument from the hand piece. Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece. Note: hold only the gray hand piece and not the instrument handle while applying the torque wrench. - close the trigger remove the torque wrench by sliding it off of the shaft. Do not dispose of the torque wrench until the procedure is completed. The torque wrench is used to remove the instrument from the hand piece following the procedure. Dispose the torque wrench only after completing the procedure. Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft. Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off 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. Note: do not touch the instrument to metal while activated. Note: do not clean the blade tip with abrasives. It can be wiped with a moist gauze sponge to remove tissue, if necessary. -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. The reported event will continue to be monitored through post-market surveillance.

 
Event Description

It was reported the harmonic scalpel was connected to the generator. Several times the unit said to retighten and eventually said to replace the device. There was minimal delay to troubleshoot and replace the device. There was no patient injury or medical intervention 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 Key6337811
MDR Text Key67955353
Report Number0001056128-2017-00033
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 02/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/22/2017
Device MODEL NumberHAR36
Device Catalogue NumberHAR36RR
Device LOT Number4845574
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2016
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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