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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Blood Loss (2597)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation. The device was discarded by the facility. As the device was not returned for evaluation, visual and functional inspection was unable to be performed. A review of the dhr could not be performed as the lot/serial number was not reported. The reported event could be attributed to: - clamping and / or activating the device without having tissue between the jaw assembly. - tissue accumulation between the blade and jaw assembly. - improper usage and inadequate cleaning of instrument. - ancillary equipment issues (hand piece / generator). 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 occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message. - incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided. - the instruments allow for the coagulation of vessels up to and including 5 mm in diameter. Do not attempt to seal vessels in excess of 5 mm in diameter. - 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. Should the device become available for return, the investigation will be reopened. The reported event will continue to be monitored through post-market surveillance. (b)(4).

 
Event Description

It was reported that through case review the physician found post-op bleeding related to the harmonic scalpel device. The patient was readmitted directly from pacu back to the or for an additional procedure. The patient was hypertensive, indicating blood loss. Blood transfusion was administered to the patient. 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 Key6211324
MDR Text Key63475951
Report Number0001056128-2016-00168
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
Type of Report Initial
Report Date 12/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHAR36
Device Catalogue NumberHAR36RR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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