MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH UROSKOP OMNIA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number UROSKOP OMNIA

Device Problems No Display/Image (1183); Output Problem (3005)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Everything was ready to go in the room for surgery and pt had already been put to sleep but when the surgery started the surgeon was not able to take x-ray, multiple attempts to fix the problem but still unable to, so new bed and x-ray machine had to be brought to the room.Routine bed maintenance completed on table in or one day prior to incident.This case was the first case performed after the bed maintenance.Routine procedure was to be performed and patient positioned as usual.When surgeon was trying to get x-ray image necessary to proceed, image was very unclear and then went black.Numerous attempts were made to get image by the surgeon without success and with the same result.Maintenance was immediately informed and brought to the or.Unable to diagnose the problem decision was made to transfer the patient to another or table in the same room and bring in a portable c-arm.This involved breaking down the sterile field, repositioning and utilization of an increased amount of disposable goods for the case.The patient was under anesthesia for an increased amount of time (approximately 45-60 minutes).I have requested a detailed report from the company who fixed the bed and have not yet received it.

• Brand Name: UROSKOP OMNIA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 2 edgewater drive; norwood MA 02062
• MDR Report Key: 8385831
• MDR Text Key: 137704827
• Report Number: 8385831
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2018

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: UROSKOP OMNIA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA