MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE LITHOTRIPSY PROBE; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PD376

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

Event Type  malfunction  

Event Description

During a right nephrolithotomy percutaneous procedure for a stone greater than 2 cm, staff reported the olympus shockpulse probe broke in half while the surgeon was breaking up the kidney stone.The probe was removed, and a new probe obtained to finish the case.

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• MDR Report Key: 11699830
• MDR Text Key: 246568901
• Report Number: 11699830
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/16/2021

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: Health Professional
• Device Model Number: SPL-PD376
• Device Lot Number: KR973908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1