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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLTA CYBERWAND ADVANCED TRANSDUCER LITHOTRIPTOR, ELECTRO-HYDRAULIC

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GYRUS ACMI INC CW-USLTA CYBERWAND ADVANCED TRANSDUCER LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number CW-USLTA
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device has been returned for evaluation. The customer¿s complaint of the physical defect was confirmed. The service technician observed device was not producing output and found missing nose cone. The cause could not be determined. No further information was reported.
 
Event Description
The customer reported to olympus that the device was not working. There was no patient injury reported.
 
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Brand NameCW-USLTA CYBERWAND ADVANCED TRANSDUCER
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, MN 55445
9013785969
MDR Report Key10388168
MDR Text Key214802499
Report Number3005975494-2020-00017
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCW-USLTA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2020
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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