MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA EVO EXCEL; GAMMA CAMERA

Model Number 10910500

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2022

Event Type  Injury  

Event Description

Siemens medical solutions usa, inc.Was notified of a patient injury that occurred on (b)(6) 2022.The operator of the device failed to follow use instructions to remove the patient from the system before reconfiguring the detectors.As a result, the patient's leg was caught between the patient bed and the detector.The patient sustained a laceration to the leg that required stitches.There are no product defects or failures.There are no labeling defects.There were no other injuries to any other persons.

• Brand Name: SYMBIA EVO EXCEL
• Type of Device: GAMMA CAMERA
• 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 ; 8472172723
• MDR Report Key: 14367846
• MDR Text Key: 292343820
• Report Number: 1423253-2022-00001
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10910500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG