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

Model Number CW-USLS

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence for additional information was executed.The device has been returned, and the product investigation is results are not yet available.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, there was no patient involvement.During preparation for use, the device did not power on.The fault light error was showing prior to rebooting.Alarms/alert tones were noted.The settings at the time are unknown.Instructions for use manual had been followed for assembly and sterilization.The transducer cable was inspected prior to use and no abnormalities were observed.Red dots on the transducer connector and generator were aligned; the transducer connector was pressed firmly into the generator transducer port.Foot switch was connected properly; it is not known if it was able to activate.The wand and generator were inspected prior to procedure.The cord connection was secure.The physician is experienced in using this device.

Manufacturer Narrative

The device, which was returned on march 10, 2020.The initial mdr, submitted without a device evaluation as it was in progress, is now completed.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h3, h6 and h10.The manufacture date is not known.The user¿s complaint was not confirmed.The device was inspected and tested.All functions and outputs were found within standard specification, the reported phenomenon could not be duplicated.Additionally, the device was observed to have one missing leg on the housing, unrelated to the reported failure.The root cause of the reported failure could not be determined as the evaluation was unable to confirm the reported phenomenon the device having functioned as intended.The device instructions for use suggests a fault indicator light may be a result of an improperly connected footswitch or transducer.Note these accessories should be plugged into the unit while the generator is powered off or the fault light will illuminate.Neither accessory was returned for evaluation.

• Brand Name: CW-USLS CYBERWAND USL SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 9917800
• MDR Text Key: 198928923
• Report Number: 2951238-2020-00403
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• PMA/PMN Number: K052135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

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-USLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1