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

Model Number	11061640
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	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a handling error.During the investigation, it was communicated that the patient was not fixed during the examination.According to the instruction for use (somatom go.Top | instructions for use, print no.C2-082b-g.621.05.03.02, chapter 2.4.4 securing the patient, page 28) it is recommended to fix and observe the patient during the examination to avoid unintentional patient movement and injury to the patient.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom go.Top ct system.On (b)(6) 2024, during an examination of a 59-year-old male patient, the plexiglass ring of the scanner was damaged.The patient bent his knee as the table moved toward the gantry during the topogram scan.As a result, the plexiglass ring broke and the patient suffered a soft tissue injury to the knee which required stitches.

• Brand Name: SOMATOM GO.TOP
• 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., mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19582679
• Report Number: 3004977335-2024-00066
• Device Sequence Number: 16979371
• Product Code: JAK
• UDI-Device Identifier: 04056869151571
• UDI-Public: 04056869151571
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K233650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 11061640
• Device Catalogue Number: 11061640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/21/2024
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male