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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 Operating System Becomes Nonfunctional (2996)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
It was reported that during a percutaneous nephrolithotomy, within 2 minutes of commencing the initial use of the instrument, the equipment failed as the fault led lit up on the console. Restarting the machine and changing the disposable tip did not fix the fault. The machine was non-operational from this time on. Per the customer, there was only one unit. As a result, the procedure was abandoned. The patient was under general anesthesia, and an incision had been made into the kidney.
 
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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
kenneth pittman
9600 louisiana avenue north
brooklyn park, MA 55445
9013785969
MDR Report Key10483078
MDR Text Key214352477
Report Number3011050570-2020-00065
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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