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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 Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device cannot adjust the intensity, unable to tune in and fault light was observed. The user performed troubleshooting and tried two different transducers however, the issue was not resolved. There was no patient involvement on this event. No user injury reported.
 
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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 Key10924650
MDR Text Key218994774
Report Number3011050570-2020-00157
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2021
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 Reuse

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