MAUDE Adverse Event Report: CYBERSONICS INC. CYBERWAND PROBE

Model Number CW-RBP

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

After the completion of the cyberwand lithotripsy, cmtee davenport st was disassembling cyberwand and noticed a screen was broken.No harm to patient.Dr.(b)(6).Dates of use: (b)(6) 2017 1510-17:15.Diagnosis or reason for use: left kidney stone.

• Brand Name: CYBERWAND PROBE
• Type of Device: CYBERWAND PROBE
• Manufacturer (Section D): CYBERSONICS INC. ; 5340 frying rd., ste 101; knowledge park; erie PA 16510
• MDR Report Key: 7154367
• MDR Text Key: 96209653
• Report Number: MW5074284
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CW-RBP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR