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

Model Number 10094910

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

Provided pictures indicate that it is likely that there has been severe impact to the end stop bolt.A noticeable imprint in the solid steel of the monitor arm, where the bolt is mounted, is visible.This can only have been caused by a considerable overload (massive impact of the bolt in the end stop).(b)(4) is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes avaible.Internal id # (b)(4).

Event Description

During maintenance of the system siemens service engineer noticed that the suspension of the monitor support arm had become loose on the uroskop omina device.The retaining bolt of the lower joint, where the swivel arm of the monitor is attached to the carrying arm, had moved sideways due to a missing snap ring on the bolt.In addition, the mechanics of the end stop, which keeps the monitor arm from moving upwards too far, was also found to be partly broken or bent.There is no patient involvement in this case.No injuries are attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures and of the returned part indicated that the damage to the mechanical end stop was caused by frequent strong pressure against the upper end stop with the monitor support arm, which led to an excessive force impacting the damaged part.This caused the bolt to become deformed.Due to frequent pressure on the upper end stop, the snap ring has fallen off over time.Spare part consumption check of the concerned system showed that no repairs have been performed on the tft support arm in the past.However, due to improper usage, several covers on the uroskop omnia have already had to be replaced.In general, it is strictly recommended not to use the damaged tft-support arm.Otherwise, the tft support arm may fall.According to operator manual/ operating instructions spring arm acrobat 3000 (page 12) the siemens service shall be contacted in case of damage of the component.The described issue was solved at the customer site by service technician with replacement of the affected part.The affected support arm for 19" displays (10398610) is no longer delivered.A successor of the support arm for 19" displays with the material number 10999410 was introduced to the market in 2014.This part replaces the affected support arm.The spare part consumption of the successor monitor support arm (10999410) shows values below the defined threshold.No general problem is known.

• Brand Name: UROSKOP OMINA
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12933477
• MDR Text Key: 288816432
• Report Number: 3004977335-2021-06983
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/06/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other