MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH UROSKOP OMNIA MAX; STATIONARY X-RAY SYSTEM

Model Number 10762473

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

The monitor support arm is an independent component purchased by siemens from a 3rd party supplier.It is delivered as a part of the whole system.Initial analysis performed at the supplier showed emerging safety element, which is placed between swivel arm and height adjustable carrying arm of the monitor support stand.The safety element serves as a preventive mechanism from dislodging of carrying arm and swivel arm from each other.Emergence of the safety element is first indication that it is undergoing increased wear.In cooperation with the supplier siemens is conducting a thorough investigation to determine the exact root cause.Siemens will be informing all potentially affected users of this issue and issue a corrective action to inspect affected systems replace parts if needed.

Event Description

During an on-site visit siemens local service engineer noticed an issue with the uroskop omnia max unit.The gap between carrying arm and swivel arm was not according to specifications.Respective actions to prevent the arms from dislodging have been taken.There is no patient involvement in this event.No injuries are attributed to this incident.

Manufacturer Narrative

The investigation showed that the locating pin and the needle bearings of the support arms were not properly lubricated resulting in extensive wear to the retaining element and the brake screw causing the monitor to dislocate.At the concerned customer site, the service technician was immediately informed about measures and further procedure until the support arm can be replaced.After the spare parts stock was corrected in february 2019 the affected support arm was replaced.Siemens released a customer safety advisory notice (ui xp004/19/s) to inform affected customers about the issue and ensure that appropriate measures were initiated until the support arms are checked and refurbished by the service organization.The corrective action to eliminate the issue was released via an ui xp006/19/s.

• Brand Name: UROSKOP OMNIA MAX
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8541100
• MDR Text Key: 145915871
• Report Number: 3004977335-2019-66062
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K101491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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: 10762473
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other