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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLSA CYBERWAND SYSTEM LITHOTRIPTOR, ELECTRO-HYDRAULIC

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GYRUS ACMI INC CW-USLSA CYBERWAND SYSTEM LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number CW-USLSA
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device will not be returned for evaluation. The cause of the reported event cannot be determined.
 
Event Description
The service center was informed that during a percutaneous nephrolithotomy with kidney stone removal, the device stopped working about an hour into the case. The user facility¿s biomedical engineer was contacted to troubleshoot the illuminated fault indicator on the unit. The unit was noted to be working; however, when the wand was maneuvered there was a break in the cable causing the fault light to come on. They tried to unplug the device and turn it back on multiple times and tested it about six times and it still was not working. They also unplugged and unhooked the pedal to see if it would start working. No unintended tissue was burnt during the procedure. The patient is currently doing fine but all of the kidney stones were not removed. The procedure was not able to be completed and the patient will be scheduled for another procedure to remove the remaining kidney stones. The patient¿s procedure has not yet been rescheduled. There was no patient injury reported. Additionally, the user facility reported that the device was inspected prior to the procedure and it was working as intended. The machine was not making any noise. The temperature of the device was also checked and it did not overheat.
 
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Brand NameCW-USLSA CYBERWAND SYSTEM
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough PA 01772
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key9741576
MDR Text Key199987883
Report Number2951238-2020-00347
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-USLSA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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