MAUDE Adverse Event Report: CYBERSONICS, INC. CYBERWAND USL TRANSDUCER; LITHOTRIPTOR, ULTRASONIC

Model Number CW-USLT

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts to obtain additional information from the user facility were unsuccessful.Pictures provides showed a kinked power cord just below the strain relief.As the subject device was not returned we are unable to determine a root cause for the reported failure.

Event Description

Medsun medwatch# (b)(4).It was reported that while a patient was undergoing a percutaneous nephrolithotomy procedure, the transducer did not work with no output.Another device was utilized; however, it failed.The procedure had to be aborted.On inspection it appeared the electrical wires of the power cable had fractured on both transducers.The company representative brought in a loaner shockpulse system the next day in order to complete the procedure for the patient.No patient harm reported.The power cable kinked at proximal end of handpiece.

• Brand Name: CYBERWAND USL TRANSDUCER
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): CYBERSONICS, INC.; knowledge park; erie PA 16510
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 9241648
• MDR Text Key: 204562398
• Report Number: 2951238-2019-01170
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-USLT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 113