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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 Problems Defective Device (2588); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated. Evaluation determined that the device was found with missing nose cone and damaged suction port, no output. Device is non repairable. The device was returned unrepaired. Customer was notified. Reported issue was found to be due to damaged suction port with missing cone attributed to component failure.
 
Event Description
It was reported that the device was found not working, issue with the probe was observed. No patient involvement on the event reported. No user 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, MA 55445
9013785969
MDR Report Key10886681
MDR Text Key219550043
Report Number3011050570-2020-00152
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 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2020
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 Manufacturer10/28/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2019
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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