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

Model Number 10094910

Device Problems Unintended Collision (1429); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The reason for collision is presently unknown.It is user's responsibility to ensure that no objects are in the collision range of the tube assembly.Investigation is ongoing.A supplemental report will be submitted if additional information becomes available.Internal id#: (b)(4).

Event Description

Siemens was informed about an incident that occurred with the uroskop omnia device.The user drove the tube assembly into a surgical light and severely damaged the tube arm assembly.The concerned unit is no longer usable.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.The provided pictures showed a severely damaged system.The tube assembly was driven against the extension arm of a ceiling surgical lamp.A system malfunction was not communicated.Since the collision monitoring cannot detect free-standing parts or other movable objects placed in the travel range of the system movement, the system couldn't stop the movement by itself.The operator must operate the system only under visual contact and must assure that no movable/external objects (e.G.Ceiling mounted surgical light) are in the collision area when initiating the system movement.This is also described in the operator manual spl5-350.620.01.02.02 / chapter "safety" on page 22 and 23 (see below).According to the room plan, the mounting point of the surgical light is outside of the system movement area.Therefore, it is possible to swivel the surgical light out of this region.It was also stated that the system is no longer usable due to the damage.The unit was inspected and it was concluded that the tube carrier and the tower must be replaced.The system requires repairs, however, due to covid-19 pandemic situation it is not possible for factory experts to travel to perform these repairs.Therefore, the repair instruction 3783300-asd-100-00 (available for service since 15.10.2020) was created and send to the user's service department.Internal id# (b)(4).

• 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: 10373376
• MDR Text Key: 220732462
• Report Number: 3004977335-2020-39845
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other