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

Model Number	CW-USLS
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the device fault indicator is illuminated with the footswitch and transducer connected.There was no patient involvement on this event reported.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of the device investigation.The returned device was evaluated.The reported complaint was confirmed.The failure was a result of a damaged foot pedal receptacle.While a definitive root cause is unknown, the damage to the receptacle is likely due to general wear and tear.The old software v1.1 needs to be upgraded to v1.2.Additionally, cosmetic damage to the housing as well as missing/damaged housing screws were noted further suggesting general wear and tear consistent with an aging unit.There is no evidence the device has previously been returned to olympus for general preventative maintenance or repair.Per page 20 of the device ifu (instruction for use), its states: olympus recommends that the unit is returned every 24 months for a calibration and safety inspection by the manufacturer.Olympus will continue to monitor complaints for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide correction on the aware date filed for the 1st supplemental report on april 21,2021.The aware date is corrected and updated from march 29, 2020 to march 29, 2021.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response and updates regarding the event reported.
Event or Problem Description
Updates on the reported event: problem was first noticed during set up of a case.No delay of procedure.The intended procedure was completed successfully with a different device.No information available for the device used.Currently customer has loaner device.No other information provided.

• Brand Name: CW-USLS CYBERWAND USL SYSTEM
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11236467
• Report Number: 3011050570-2021-00031
• Device Sequence Number: 4228426
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLNC2
• UDI-Public: H891CWUSLNC2
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CW-USLS
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/29/2020; 04/27/2021; 04/29/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/21/2021; 04/27/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1