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

Model Number CW-USLTA

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

The cyberwand advanced transducer was returned to the service center for evaluation.The evaluation confirmed the reported unit was not responding as there was no output; faulty transducer.Additionally, the device was missing the nose cone.The user facility traded-in the (non-repairable) device for a new transducer.The cause of the reported event cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use, the cyberwand advanced transducer did not respond when plugged in.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide new information from the investigation results.Based on the investigation, a definitive root cause could not be determined.However, a review of manufacturing records indicates the unit met all final release criteria prior to shipment.This includes passing all functional and electrical tests defined by the manufacturer's work instruction prior to packaging.

• 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: 10217937
• MDR Text Key: 201583677
• Report Number: 3011050570-2020-00013
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CW-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1