MAUDE Adverse Event Report: CYBERSONICS INC. SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE, SINGLE USE, 3.76MM; ELECTROHYDRAULIC LITHOTRIPTOR.

Model Number	SPL-PD376
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to cybersonics for evaluation.A review of similar reported complaints indicates that this reported phenomenon is likely attributed to excessive force applied on the device, and/ or excessive bending during the procedure.
Event or Problem Description
Shockpulse lithotripsy probe broke inside the patient.Broken piece is retrieved from the patient.No injury or health hazard was reported to the patient.

• Brand Name: SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE, SINGLE USE, 3.76MM
• Common Device Name: ELECTROHYDRAULIC LITHOTRIPTOR.
• Manufacturer (Section D): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• MDR Report Key: 8106152
• Report Number: 3004216443-2018-00006
• Device Sequence Number: 1997976
• Product Code: FEO
• UDI-Device Identifier: 00855279005030
• UDI-Public: (01)00855279005030(17)221017(10)D1700842
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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
• Operator of Device: Health Professional
• Device Model Number: SPL-PD376
• Device Lot Number: D1707047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1