MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLSA CYBERWAND SYSTEM; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number CW-USLSA

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported that during a percutaneous nephrolithotomy, within 2 minutes of commencing the initial use of the instrument, the equipment failed as the fault led lit up on the console.Restarting the machine and changing the disposable tip did not fix the fault.The machine was non-operational from this time on.Per the customer, there was only one unit.As a result, the procedure was abandoned.The patient was under general anesthesia, and an incision had been made into the kidney.

Manufacturer Narrative

This report is being supplemented to provide additional information (d11, h10) regarding the reported event.Additional information received identified that per the customer, the device was visually inspected and passed the tuning process before being used on the patient.It was also reported the patient completed their treatment the following week.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer for medical device report.The customer returned the referenced cw-uslsa cyberwand lithotripsy system.The evaluation of the confirmed system noted no defect or function deficiency with the generator but noted the returned transducer was non-functional.As the transducer was not returned to the manufacturer for further diagnostic testing a definitive root cause is no known.The transducer is non-serviceable, a replacement has been recommended (by oaz).This device was manufactured in december 2013 by cybersonics inc.Dhr records were provided to olympus for review and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Although the cause of the reported event is unknown, considering the age of the generator (manufactured in 2013) failure of the transducer may be a result of general wear and tear due to age.As stated on the ifu and as a preventive measure, the user manual states: the transducer is validated for 100 use cycles.Olympus will continue to monitor complaints for this device.

• Brand Name: CW-USLSA CYBERWAND SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10483078
• MDR Text Key: 214352477
• Report Number: 3011050570-2020-00065
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-USLSA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/25/2020; 01/26/2021
• Supplement Dates FDA Received: 10/02/2020; 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS NEPHROSCOPE; PLASTIC SHEATH