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

Model Number 10094910

Device Problem Use of Device Problem (1670)

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

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The user was informed by siemens to take the concerned system out of use immediately as safe attachment of the tube carriage cannot be ensured under these circumstances.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).

Event Description

Siemens local service engineer identified an issue with the uroskop omnia system.The tube frame became misaligned and slightly bent.At least three bolts that secure the tube frame were broken.Therefore, the tube carriage longitudinal linear bearing rail was not securely fastened to the frame.Under these circumstances a safe operation of the system could not be ensured.There is no patient involvement in this event.

Manufacturer Narrative

The issue was investigated in detail.During onsite visit the service engineer attempted to align the tube and found that the tube carriage longitudinal linear bearing rail was not securely fastened to the frame and flexing.At least 4 of 8 bolts were found damaged and the frame was slightly bent.The provided pictures showed massive damage at the tube carrier.According to the information from the customer, patients regularly use the collimator "handle" to position themselves onto or off the table.The user decided not to repair the concerned unit but to replace the whole system with uroskop omnia max.Since the replacement was done by an external service organization, it was not possible to return the defective parts or the whole damaged basic unit for further investigation.Therefore, this analysis is based on the available information and pictures provided by the supplier of the original unit.This investigation showed that one bolt from the guiding rail of the tube carrier was completely drawn out and three other bolts were partly drawn out of their mounting place.Furthermore, there was severe deformation of the tube carrier itself.Only massive force amplified by the leverage (design of the tube carrier) could cause such a damage.Based on the data sheet of the used screws some calculations regarding the maximum load were performed.Taking into consideration all tolerances, it was concluded that an overload exceeded eight times the permitted overload to damage the tube carriage in the described manner.Also, the customer's statement that patients regularly use the collimator "handle" to position themselves was analyzed.However, this statement can be excluded as a single root cause of the damaged tube carriage.The allowed force at the handle is 40kg / 400n.There is also reflected on the label at the tower.The experts state that the most probable cause of this kind of damage was a collision of the tube carriage with an obstacle in the movement path and not a misuse of the handle.Only fixed objects are considered for the collision calculation of the system, the operator must ensure that the system movement path is free of movable obstacles such as stools, equipment trolleys etc.The original unit at the concerned site was replaced.No general problem in the field could be identified.

• Brand Name: UROSKOP OMNIA
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 9786081
• MDR Text Key: 190966508
• Report Number: 3004977335-2020-20754
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K101491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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: 10094910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other