UROSKOP OMNIA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for UROSKOP OMNIA manufactured by Siemens Ag/siemens Healthcare Gmbh.

Event Text Entries

[137704827] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8385831
• MDR Report Key: 8385831
• Date Received: 2019-03-04
• Date of Report: 2018-12-20
• Date of Event: 2018-12-12
• Report Date: 2018-12-20
• Date Reported to FDA: 2018-12-20
• Date Reported to Mfgr: 2019-03-04
• Date Added to Maude: 2019-03-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: UROSKOP OMNIA
• Generic Name: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Product Code: JAA
• Date Received: 2019-03-04
• Model Number: UROSKOP OMNIA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SIEMENS AG/SIEMENS HEALTHCARE GMBH
• Manufacturer Address: 2 EDGEWATER DRIVE NORWOOD MA 02062 US 02062

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-04