MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM SCOPE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10967666
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom scope ct system.On (b)(6), 2022, it was reported that an an operator injured his finger on the aluminum plate of the sealing flap when he tried to move the mcs (monitor ceiling system).The operator was treated and received one stitch to the finger.We are unaware of any further impact to the state of health of the operator.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Our technical experts analyzed the provided picture and noticed tape on the sealing flap.However, when the monitor ceiling system (mcs) is delivered by siemens to customers, it comes without tape.It was also confirmed that the concerned mcs was dented and not in proper state.Based on the input from the supplier, the sealing flap at the customer site has been incorrectly mounted or dissembled.According to siemens local service engineer, disassembly or mounting was not performed by siemens.Manufacturer's instructions for use clearly indicate not to use the damaged system and that local service should be contacted for repairs.A regular inspection of the mcs should be performed by the user as well.The concerned unit is working as designed, and the reported event was caused by a user error.

• Brand Name: SOMATOM SCOPE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15292433
• Report Number: 3004977335-2022-38475
• Device Sequence Number: 17968946
• Product Code: JAK
• UDI-Device Identifier: 04056869010311
• UDI-Public: 04056869010311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 10967666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/27/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown