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

Model Number	CW-USLTA
Medical Device Problem Codes	No Device Output (1435); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during preparation for use, the device would not work.Customer stated that they did the tuning, shut down the device and turned it on and would not work.Customer used another transducer and had no issues.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.In a follow up communication with the customer, it was conveyed that the facility decided not to repair the device.There are no further information provided.The root cause of the reported issue cannot be determined as this time.Investigation is ongoing.This report will be supplemented following investigation.
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, h6 and h10.As no device is returning to olympus, a device evaluation could not be performed.No findings are available.The observed failure is a known phenomenon that may likely have been a result of a lack of ensuring all connections and cables were proper prior to use.On page 4 of the device ifu (80862 rev ag), it states: "thoroughly inspect all electrical cables and probes before each use.Do not use if there is any evidence of deterioration.Replace if any damage or excessive wear is observed.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
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 12862842
• Report Number: 3011050570-2021-00127
• Device Sequence Number: 11850065
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLTA2
• UDI-Public: H891CWUSLTA2
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown