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

Model Number	11061660
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go.Sim ct system.It was reported that a ct technologist cut her right index finger on the underside of the radiation tabletop due to a sharp edge while removing the headrest.The technologists' finger was cleaned, and bandaged, and no further medical treatment was required.The service engineer checked the involved hardware, and no visible irregularities were observed on the table, tabletop, or headrest.Siemens has requested additional information in order to conduct an investigation of the reported event.Following the investigation, a supplemental report will be filed if a device malfunction is identified.
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.Following the investigation, a supplemental report will be filed if a device malfunction is identified.

• Brand Name: SOMATOM GO.SIM
• 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: 15825368
• Report Number: 3004977335-2022-50647
• Device Sequence Number: 6143134
• Product Code: JAK
• UDI-Device Identifier: 04056869249230
• UDI-Public: 04056869249230
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K192061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: 11061660
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/18/2022
• 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: Other
• Patient Sex: Unknown