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

Model Number	11061620
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/13/2023
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.Up ct system.During examination, while the table was being driven, the patient¿s finger was pinched between the tabletop support and the tabletop.As a result, the patient suffered a laceration to the finger which required four stitches.We are unaware of any further impact to the state of health of the patient involved.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.An evaluation of the system revealed that the gap dimensions of the patient table have been investigated and found within specification.According to the owner¿s manual (instructions for use), it is recommended to place patient's arms on their body and to use positioning aids when necessary and to observe the patient during all system movements and to press the stop key in urgent situations.Based on available information the system worked as specified.No further measures are deemed to be necessary.

• Brand Name: SOMATOM GO.UP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~ or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17497611
• Report Number: 3004977335-2023-00085
• Device Sequence Number: 16742736
• Product Code: JAK
• UDI-Device Identifier: 04056869051314
• UDI-Public: 04056869051314
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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: 11061620
• Device Catalogue Number: 11061620
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown