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U.S. Department of Health and Human Services

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

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GYRUS ACMI INC CW-USLS CYBERWAND USL SYSTEM LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number CW-USLS
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated. Evaluation determined that the reported issue was confirmed. The device footswitch foot pedal was pushed into the unit. In addition, minor scratches were observed on the housing with broken screw. Unit was found with old software version and needs to be upgraded. The device was placed for repair. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that during preparation for use the footswitch device was found damaged, foot pedal was pushed into unit. There was no patient involvement on this event. No user injury reported.
 
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Brand NameCW-USLS CYBERWAND USL SYSTEM
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough PA 01772
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10856285
MDR Text Key225931128
Report Number8010047-2020-09033
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-USLS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2021
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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