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 Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint was confirmed.There was no output and the device was getting hot.The nose cone was found to be missing.This a non-repairable item.

Event Description

The service center was informed that the cyberwand transducer failed during or shortly after tuning.The display says fail on the machine.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.Please see the updates in sections: g4, g7, h2, h4, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.Upon evaluation of the returned device, the complaint was confirmed.The transducer was non-functional.As the unit was returned unrepaired per request of the customer, the device was not made available to osta market quality for destructive testing therefore a true root cause could not be determined.Review of dhr records provide no indication manufacturing processes contributed to the reported event.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Failure of the transducer is likely a result of general wear and tear due to the age of the device.Per page 17 of the device ifu the transducer "has a validated lifetime of 100 reuses.Follow hospital procedure for tracking number of uses." it is unknown how many use cycles this particular devices has undergone.This device was manufactured 05mar2014 by cybersonics inc.Dhr records were provided to olympus for review.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.This unit was produced under job number 50003480 with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.

• 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: 10444611
• MDR Text Key: 205006211
• Report Number: 3011050570-2020-00051
• 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
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 08/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1