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

Model Number CW-USLTA

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation determined that the reported issue was not able to be duplicated.The suction port was found with a big dent, however, no other functional issues were observed.The device was tested and all functions were found to be within standard specifications, no issues were observed.Further testing found that the unit worked with the reference generator with no issues or abnormalities noted.In addition, the unit was tested with the customer returned generator ((b)(4)), and the unit worked properly with no issue observed.Additionally, burn in testing was performed and the unit passed testing with no issues observed.Based on evaluation findings the reported issue was not confirmed as the device passed all testing with no issues, or abnormalities observed.

Event Description

It was reported that during an unspecified procedure the device transducer motor stopped working after being in use for 5 minutes.The user power cycled the device for a few minutes.The intended procedure was not completed.There were no other details provided regarding the event.There was no patient harm or injury reported.No user injury reported.This report is related to reports with patient identifiers: (b)(6).

Manufacturer Narrative

This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

Manufacturer Narrative

This supplemental report is being submitted to provide customer response and updates.Further communication with the customer conveyed the following information : the intended procedure was a lithotripsy.It was reported that the procedure could not be done and was not started at all.It is unknown if the procedure was rescheduled.There were no errors, warnings, alerts or alarms received.This issue occurred when they were setting up.

• 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: 11055447
• MDR Text Key: 223164061
• Report Number: 3011050570-2020-00189
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1