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

Model Number CW-USLTA

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the service center for evaluation.The cause of the reported event cannot be determined.

Event Description

The service center was informed that during a percutaneous nephrolithotomy (pcnl) procedure, the transducer did not tune the probe and no activation took place.The intended procedure was completed with a similar device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Please see the updates in sections: g4, g7, h2 and h10.A definitive root cause could not be determined, as the device has not been made available to osta market quality for evaluation.Based upon review of production records and complaint history, there is no reason to suggest systemic failure of this lot.The reported failure may be a result of user error.The device was manufactured by cybersonics inc.In july 2019, the dhrs have been made available 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.A total of 30 units were produced under this job number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.If the device becomes available at a later date the complaint will be updated accordingly.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.The customer returned a cw-uslta cyberwand lithotripsy transducer for evaluation.Upon evaluation of the returned device, the complaint could not be confirmed as the unit was inspected and functionally testing with no functional problem found.The device was returned to the customer un-repaired.The legal manufacturer reported that a definitive root cause could not be determined.The reported failure may have been a result of user error.See the device ifu for instructions regarding handling, assembly and proper tuning procedures.

• 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: 9962511
• MDR Text Key: 219136619
• Report Number: 2951238-2020-00421
• 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,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1