MAUDE Adverse Event Report: CYBERSONICS INC. SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MM; ELECTROHYDRAULIC LITHOTRIPTOR.

Model Number SPL-PR340

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to cybersonics for evaluation.The event occurred during reuse of the device.Instructions for use (ifu) of the device recommends 5 reuses.It is not clear how many times the device has been reused.A review of similar reported complaints indicates that this reported phenomenon is likely attributed to excessive force applied on the device, excessive use of the device and/ or excessive bending during the procedure.

Event Description

The doctor was performing percutaneous nephrolithotomy procedure (pcnl) and during the procedure, probe broke.The doctor removed the probe from the patient and continued the surgery using another probe.No injury or health hazard was reported to the patient.

• Brand Name: SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MM
• Type of Device: ELECTROHYDRAULIC LITHOTRIPTOR.
• Manufacturer (Section D): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• Manufacturer (Section G): CYBERSONICS INC.; 5340 fryling road; suite 101; erie PA 16510 4703
• Manufacturer Contact: samradni patil ; 5340 fryling road; suite 101; erie, PA 16510-4703 ; 8149201510
• MDR Report Key: 8015477
• MDR Text Key: 125349209
• Report Number: 3004216443-2018-00005
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005184
• UDI-Public: (01)00855279005184(11)161101(10)W1606012
• Combination Product (y/n): N
• PMA/PMN Number: K171024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-PR340
• Device Lot Number: W1605902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1