MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA T6; GAMMA CAMERA

Model Number 10275009

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

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 08/04/2022

Event Type  Injury  

Event Description

Siemens medical solutions usa, inc.Was notified on august 31, 2022, of a patient injury that occurred on (b)(6), 2022, at the end of an acquisition.Motion was initiated by the operator to remove the patient.The operator failed to follow the instructions to keep body parts away from the contact and pinch points within the patient bed pallet.As a result, the patient's fingers were caught in a patient bed pallet pinch point.The patient sustained an injury to the fourth and fifth fingers of the left hand that required surgical intervention.There are no product defects or failures.There are no labeling defects.There were no other injuries to any other persons.

• Brand Name: SYMBIA T6
• 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 ; 8472172734
• MDR Report Key: 15414149
• MDR Text Key: 299813443
• Report Number: 1423253-2022-00002
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10275009
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 76 KG