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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 Problems Mechanical Problem (1384); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was evaluated. Evaluation determined that the reported issue was confirmed. The issue was found to be due to a broken foot pedal receptacle. In addition, minor scratches on the housing was observed. The identified parts were replaced, device was repaired. Software was upgraded. Once completed, the device was tested and passed required testing and specifications. Based on evaluation findings, the reported issue was confirmed. The root cause of the issue was due to a broken foot pedal attributed to component mechanical failure.
 
Event Description
It was reported that the device cw-uslsa cyberwand system does not rotate. The issue was found during a pm (preventive maintenance) service. There was no user harm or injury reported on this event.
 
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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 ave. north
brooklyn park, MN 55445
9013785969
MDR Report Key10350603
MDR Text Key220723720
Report Number3011050570-2020-00026
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
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 Manufacturer06/26/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2020
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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