MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA INTEVO 2; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number	10764802
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Crushing Injury (1797); Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens medical solutions usa, inc.Was notified on may 28, 2024, of a siemens customer service engineer injury that occurred on (b)(6) 2024.Allegedly, the engineer sustained a finger injury that required surgical intervention while servicing the device contrary to the service instructions.The service engineer was troubleshooting the system trying to isolate a noise related to the pulley belt.The service engineer placed their finger too close to the belt, which allowed contact between his finger and the moving belt, and causing the injury.No labeling or product defects were found.The described event cannot cause injury to patients or operators in a clinical setting.

• Brand Name: SYMBIA INTEVO 2
• Common Device Name: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 n. barrington rd.; hoffman estates, IL 60192 ; 8472172734
• MDR Report Key: 19627539
• Report Number: 1423253-2024-00007
• Device Sequence Number: 7400074
• Product Code: KPS
• UDI-Device Identifier: 04056869001227
• UDI-Public: (01)04056869001227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: Other
• Device Model Number: 10764802
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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: Required Intervention
• Patient Sex: Male