MAUDE Adverse Event Report: CYBERSONICS, INC. SHOCKPULSE LITHOTRIPSY PROBE, SINGLE USE 3.40 MM (3/BOX); LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX340

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Type  malfunction  

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 and/or bending during the procedure.

Event Description

Probe broke during bladder stone removal procedure and had to be removed from patient.All parts were retrieved and there were no complications reported.

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE, SINGLE USE 3.40 MM (3/BOX)
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): CYBERSONICS, INC.; knowledge park; 5340 fryling rd, suite 101; erie PA 16510 4703
• Manufacturer (Section G): CYBERSONICS, INC.; knowledge park; 5340 fryling rd, suite 101; erie PA 16510 4703
• Manufacturer Contact: wendy bond ; knowledge park; 5340 fryling rd, suite 101; erie, PA 16510-4703 ; 8148984734
• MDR Report Key: 8667684
• MDR Text Key: 146960026
• Report Number: 3004216443-2019-00004
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-PDBX340
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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