MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA INTEVO 16; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number	10764804
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens medical solutions usa, inc.Was notified on april 11, 2024, of a customer service engineer injury that occurred on (b)(6) 2023.Allegedly, the engineer sustained a fracture and laceration injury to his finger that required stitches, while servicing the device contrary to the service instructions.No labeling or product defects were found.The described event cannot cause injury to patients or operators while in clinical use at a user facility.

• Brand Name: SYMBIA INTEVO 16
• 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: 19288202
• Report Number: 1423253-2024-00005
• Device Sequence Number: 7143113
• Product Code: KPS
• UDI-Device Identifier: 04056869001241
• UDI-Public: (01)04056869001241(21)2005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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: 10764804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male