MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. CIOS SELECT; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10893686
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The system is working as specified and the adverse event was the result of user error.The system is designed to prevent possible crushing as far as possible.It has been designed and tested in accordance with iec 60601-1.Despite all precautions, residual gaps remain between the moving and stationary parts of the system for mechanical reasons.Therefore, warning stickers have been attached to the system at these points and the remaining areas of risk have been described in detail or even illustrated in the instructions for use.The operator manual of the cios select system indicates the hazardous locations around the system in chapter 2.2 personal safety --> 2.2.2 crushing hazards on the c-arm system: correct handling of the c-arm system requires that operating personnel and patients use only the handles provided for this purpose.Where this is not possible, monitor the points of potential crush injury between movable system parts and their guide openings.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the cios select system.During a procedure, while the doctor was rotating the c-arm, the technician grabbed rotating parts of the c-arm, resulting in a distal phalanx fracture.There is no report of impact to any patient involved.
Additional Manufacturer Narrative
Correction made to udi# provided in initial report.

• Brand Name: CIOS SELECT
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1 ~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18189748
• Report Number: 3003202425-2023-00004
• Device Sequence Number: 7237880
• Product Code: OWB
• UDI-Device Identifier: 04056869028132
• UDI-Public: (01)04056869028132(21)13136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10893686
• Device Catalogue Number: 10893686
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown