MAUDE Adverse Event Report: CYBERSONICS INC. SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX); ELECTROHYDRAULIC LITHOTRIPTOR, PRODUCT CODE: FEO

Model Number	SPL-PDBX376
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to cybersonic for evaluation.A review of similar reported complaints indicate that this reported phenomenon is likely attributed to excessive force applied on the device and/ or excessive torqing during the procedure.It is not clear how the additional hole was caused practically.
Event or Problem Description
The user facility reported that during a lithotripsy procedure the lithotripsy probe broke off six inches from the seating thread.An extra hole was made in an attempt to locate the broken piece.

• Brand Name: SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX)
• Common Device Name: ELECTROHYDRAULIC LITHOTRIPTOR, PRODUCT CODE: FEO
• Manufacturer (Section D): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• MDR Report Key: 7876514
• Report Number: 3004216443-2018-00002
• Device Sequence Number: 186666
• Product Code: FEO
• UDI-Device Identifier: 10855279005037
• UDI-Public: (01)10855279005037(17)221226(10)D1700851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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 Expiration Date: 12/26/2022
• Device Model Number: SPL-PDBX376
• Device Lot Number: D1700851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1