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

Model Number CW-USLS

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

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 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.

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.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates regarding the event reported.

Event 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
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11236467
• MDR Text Key: 250463896
• Report Number: 3011050570-2021-00031
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLNC2
• UDI-Public: H891CWUSLNC2
• Combination Product (y/n): N
• PMA/PMN Number: K052135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CW-USLS
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 03/29/2020; 04/27/2021; 04/29/2021
• Supplement Dates FDA Received: 04/21/2021; 04/27/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1