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

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 08/17/2018

Event Type  malfunction  

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 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)
• Type of Device: ELECTROHYDRAULIC LITHOTRIPTOR, PRODUCT CODE: FEO
• 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: 7876514
• MDR Text Key: 120258927
• Report Number: 3004216443-2018-00002
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 10855279005037
• UDI-Public: (01)10855279005037(17)221226(10)D1700851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2022
• Device Model Number: SPL-PDBX376
• Device Lot Number: D1700851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1