MAUDE Adverse Event Report: CYBERSONICS INC LITHOTRIPSY PROBE, STERILE SINGLE USE SHOCKPULSE-SE; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PD340

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2017

Event Type  malfunction  

Event Description

Patient came to operating room for cystoscopy with lithotripsy.Surgeon was using shock pulse machine with shock pulse probe.Shock pulse probe broke in half.A new probe was opened and used to complete procedure.Manufacturer response for lithotripsy probe, olympus lithotripsy probe (per site reporter): manufacturer provided rga# for product return evaluation.

• Brand Name: LITHOTRIPSY PROBE, STERILE SINGLE USE SHOCKPULSE-SE
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): CYBERSONICS INC; knowledge park, 5340 fryling road; suite 101; erie PA 16510
• MDR Report Key: 6897755
• MDR Text Key: 87520696
• Report Number: 6897755
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

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
• Device Operator: Physician
• Device Expiration Date: 05/15/2022
• Device Model Number: SPL-PD340
• Device Catalogue Number: SPL-PD340
• Device Lot Number: W1700704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 79