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

Model Number	10762473
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the report facility contact name was provided in japanese characters and was not translated to english.The reporting facility phone number is (b)(6).H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the cause for the cover to fall off has not been determined yet.The investigation is on-going.A supplemental report will be submitted if additional information is received upon completion of the investigation.
Event or Problem Description
The plastic cover on the joint of the monitor support arm fell off during an examination and hit a patient in the face.No injury occurred.It was communicated that the cover(s) could be clipped back on.The covers consist of two half-shells.It is currently unclear whether one or both half-shells/covers fell off and how the cover(s) could detach from the monitor support arm.Further information was requested for investigation.Each half-shell weighs only about 100g, but, since in this case the patient¿s face was hit, it is assumed that in worst case scenario a serious injury might occur if a cover would hit a person¿s eye with a sharp corner.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.It was stated that a monitor support arm cover had fallen off at the uroskop omnia max.The investigation of the provided pictures did not indicate any damage to the affected covers.All snapping latches appeared undamaged.A deeper analysis showed that the attachment via the four snapping latches and the additional central snap lock on each side is very strong and the cover cannot snap off under normal conditions.Even with one damaged central locking point the other snap locks are very strong and hold the covers tight.Attemps were made to recontruct this issue with collision tests on a test system.There was only one constellation found that led to a snap off of the cover when both arms of the monitor boom had to be crashed together with very high force.However, in this case the position of the affected part is not near the patient table.During the tests it was discovered that for the reattachment of the cover it must be carefully checked if it is snapped in correctly.The design of the snap lock of this cover was evaluated as sufficient.In the course of previous maintenance for the monitor support arm, it was required to remove and reattach the cover.A singular workmanship error during that maintenance might be possible.The maintenance for the monitor support arm was performed in november 2020 on this system.Otherwise, this part stayed attached for about three years.It cannot be excluded that during this time span the handling of the monitor boom might have contributed to the part falling off.In the operator manual from the supplier (b)(4) it is described that damage to property is possible if the suspension system is not moved carefully.According to post market surveillance there is no indication for a general problem in the field.Since the covers were found still completely intact at the customer site, they were reattached properly and the issue has been resolved.The complaint is closed without further measures.

• Brand Name: UROSKOP OMNIA MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17743538
• Report Number: 3004977335-2023-00115
• Device Sequence Number: 5282039
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: 04056869008981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10762473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown