MAUDE Adverse Event Report:; TABLE, CYSTOMETRIC, ELECTRIC

Device Problem Positioning Problem (3009)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Following scheduled cystoscopy and right ureteral stent insertion by surgeon, patient was repositioned from lithotomy to supine position on the table.The technician stated he was having difficulty with correct positioning of the table for the extracorporeal shockwave lithotripsy (eswl) part of the procedure.He contacted his company and attempted twice to recalibrate the machine/ table, but it still was not responding correct.The surgeon, charge nurse, and or manager were notified.This part of the procedure was cancelled, and patient was transported to pacu.

• Type of Device: TABLE, CYSTOMETRIC, ELECTRIC
• MDR Report Key: 8627173
• MDR Text Key: 145621867
• Report Number: 8627173
• Device Sequence Number: 1
• Product Code: MMZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019,05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA