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

Model Number CW-USLTA

Device Problem Electrical Power Problem (2925)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated for the user reported problem of "when you try to tune it, it makes no noise and gives a fault on the box." the user reported problem was confirmed and the cause assigned to broken wires inside the cord end to the transducer body, likely caused by user mishandling.

Event Description

The user facility reported to olympus that the device made no noise and "generated a fault on the box" when attempting to tune the device.No patient injury or harm was reported associated with the problem.The intended procedure is unknown.It is unknown if the procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information.

Event Description

The user facility provided additional event information: no patient injury associated with the reported problem occurred.The reported problem was found during equipment testing.

Manufacturer Narrative

This supplemental mdr is being submitted to provide the final results of the device evaluation and device history record (dhr) review.Updates to section h6.The failure was attributed to broken wires inside the cord to the transducer body.Damage to the wires is likely a result of general wear and tear.Review of the dhr determined that the device passed all visual inspection and functional testing.

• Brand Name: CW-USLTA CYBERWAND ADVANCED TRANSDUCER
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 9995792
• MDR Text Key: 218494744
• Report Number: 2951238-2020-00432
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1