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

Model Number CW-USLSA

Device Problem Output Problem (3005)

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).

Manufacturer Narrative

The customer returned the generator for evaluation however, service repair noted that it was unable to duplicate the ur (user's request) reported issue of " the cable that came from the uslta when activated it caught fire and flames shot out of the handpiece" due to model.Service repair noted the device is an outdated model with no tools for testing.As the device returned to servicing, the result was the initial complaint could not be confirmed since the testing equipment was not available since this is an outdated model.Further, since the serial number provided was not in the system, a dhr ( device history record) review could not be performed.Additionally, service repair noted no history found on the device.The customer was informed about the findings and the device was returned unrepaired.Customer was advised to contact their olympus representative to obtain a new generator and upgrade.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.A device history record review could not be performed due to there not being record of this serial number in the olympus system.Based on the investigation results, and since no device malfunction was confirmed during 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-USLSA CYBERWAND SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14312431
• MDR Text Key: 293086382
• Report Number: 3011050570-2022-00054
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLG2
• UDI-Public: H891CWUSLG2
• 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
• 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-USLSA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• 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?: No
• 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: TRANSDUCER HANDPIECE