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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 Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The device was visually inspected and the wire to the hand piece body was found to be torn. This has been determined to be a reportable malfunction. The cause cannot be conclusively determined.
 
Event Description
The device was returned to the manufacturer without a reported complaint. Although requested, additional information has not been received.
 
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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 Key10111682
MDR Text Key214802267
Report Number3005975494-2020-00009
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 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
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 Manufacturer04/28/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2020
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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