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

Model Number	CW-USLTA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection found no tune due to faulty transducer.In addition, the nose cone on the device was found missing.Device is non repairable.Customer was informed about the inspection and was advised that the device is non repairable.Device returned unrepaired.Based on evaluation findings the reported failure was found to be due to faulty transducer.The root cause of the failure is unknown.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that the device probe was not working, when try to tune, there is no display, just three (3) little lights.The user tried another transducer and was noted to be working.Lot number of the transducer used not provided.The issue occurred during preparation for use.No patient involvement, no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.Customer reported they were able to operate a different transducer indicating the root cause is due to the faulty transducer.Instruction for use (ifu) stated the transducer has a validated lifetime of 100 reuses, the number of uses by the customer is unknown.However, over usage of the transducer could have contributed to the failure.As stated on the ifu (instruction for use) : caution: the cyberwand transducer has a validated lifetime of 100 reuses.Device history record was reviewed and showed the product met all specifications upon release.Olympus will continue to monitor the field performance of this device.

• Brand Name: CW-USLTA CYBERWAND ADVANCED TRANSDUCER
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11494711
• Report Number: 3011050570-2021-00053
• Device Sequence Number: 5349840
• Product Code: FFK
• UDI-Device Identifier: 00855279005320
• UDI-Public: 00855279005320
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: CW-USLTA
• Device Catalogue Number: CW-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1