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

Model Number CW-USLTA

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Event Description

It was reported that when the cw-uslta was activated with the cyberwand generator, the cable caught fire and flames shot out of the end of the handpiece.Customer site facility biomed confirmed that the handpiece was not in the patient at the time of the incident, the user had the handpiece in his hand testing the handpiece.The issue occurred during an unspecified procedure.The intended procedure according to the customer completed with another device.Customer site biomed confirmed that the fire reported to have come from the transducer tip.It was not from the generator and there was no patient injury.There was no patient harm or injury reported due to the event.No user injury reported.This report is related to a report with patient identifier (b)(6) (generator).

Manufacturer Narrative

The subject device was not returned for evaluation.In a follow up communication with the customer, it was conveyed that the device is not returning.Customer stated they did not discarded the device but kept it in the facility.The customer stated that the device cable was burned and cannot be tested and therefore they will not return for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.As the device did not return to olympus, a physical device inspection could not be performed.Further, the serial number provided was not in the system, a device history record review could not be performed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the investigation results, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The following information is stated in the instructions for use: "never attempt to service the device when it is connected to a power source.Hazardous voltages inside the device may cause severe electrical shock.Disconnect the power cord before servicing." olympus will continue to monitor field performance 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
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14312262
• MDR Text Key: 290969226
• Report Number: 3011050570-2022-00053
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLTA2
• UDI-Public: H891CWUSLTA2
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GENERATOR