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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.
 
Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.The following sections were updated: g4, g7, h2 and h10.
 
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Brand Name
CW-USLSA CYBERWAND SYSTEM
Type of Device
LITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough PA 01772
MDR Report Key10924650
MDR Text Key218994774
Report Number3011050570-2020-00157
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
PMA/PMN Number
K120303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberCW-USLSA
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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