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

Model Number CW-USLTA

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device was found with missing nose cone and damaged suction port, no output.Device is non repairable.The device was returned unrepaired.Customer was notified.Reported issue was found to be due to damaged suction port with missing cone attributed to component failure.

Event Description

It was reported that the device was found not working, issue with the probe was observed.No patient involvement on the event reported.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Review of dhr records provided no indication that manufacturing contributed to the reported failure.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The subject device is non-serviceable and was returned to the customer unrepaired therefore the device was not made available for further destructive testing.For this reason a definitive root cause could not be determined.Damage to the suction barb may indicate improper reprocessing which may result in the reported failure.As stated on the ifu (instruction for use) the user manual states: after each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for tears, cracks or other signs of damage.Never use damaged equipment.The cyberwand transducer has a validated lifetime of 100 reuses.Follow hospital procedure for tracking number of uses.After each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for tears, cracks or other signs of damage.Never use damaged equipment.Follow proper steam sterilization parameters.Olympus will continue to monitor complaints for this device.

• 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: 10886681
• MDR Text Key: 219550043
• Report Number: 3011050570-2020-00152
• 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: 01/26/2021

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-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1