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

Model Number 10094910

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported issue is on-going.A supplemental report will submitted if additional information becomes available.

Event Description

Siemens was informed about damages to the uroskop omnia unit.The tube carriage or the mounting rails were reported to be bent.The local service engineer provided pictures with damages to the system, however, no parts have fallen off.The falling parts could cause serious injuries in the worst case scenario.Presently siemens is not aware of any patient involvement or injury attributed to this case.

Manufacturer Narrative

E1: customer facility canadian province was added.H3, h6: siemens healthineers investigated the complaint issue in detail.It was initially stated that the tube carriage/mounting rail of the uroskop omnia was damaged.According to the information received, there was a collision with the operating room boom (or boom) while the system was being moved for cleaning.There was no patient involvement, and no one was injured due to this issue.The investigation showed that the operator did not use the system according to the system documentation.Before moving the system, the operator did not check if there were any objects within the collision zone of the system.The user always needs to watch out for objects within the collision zone of the system before initiating a movement.It is described in the operator manual to remove any objects from the collision area.To avoid the risk of collision, that could result in injury to persons or damage to equipment, the system shall only be operated under visual contact as stated in the system operator manual.The images provided show that the tube carriage mounting rail has been damaged.It was requested that the system should not be used until the affected components have been repaired.To fix the issue, it is recommended to replace the complete system long assembly of the system (set system long la, material number 10992668).Shs internal post market surveillance does not indicate a general problem for the affected part.The system experts do not assume that there is a risk of falling parts due to the collision.Since the mechanical connections are still in place, a loosening of the tube carrier is unlikely, and the internal wiring helps to prevent the tube carrier from sagging.The described issue will be solved on site by service engineers and system experts from germany with replacement of the affected part.According to the information from the service organization, the repair is planned to be completed in february 2024.Since no system malfunction was identified the complaint is closed without further measures.

• Brand Name: UROSKOP OMNIA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17911358
• MDR Text Key: 325344938
• Report Number: 3004977335-2023-00129
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Model Number: 10094910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1