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

Model Number 08717741

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Suture Abrasion (2497); Skin Tears (2516)

Event Date 06/19/2015

Event Type  Injury  

Event Description

Manufacturer narrative: on 06/22/2015 siemens became aware of a complaint event that indicated a patient sustained a shallow cut to their left hand during the movement of the symbia system bed by the operator.On 06/30/2015 in response to a request for additional information to investigation this complaint, siemens was informed that the patient cut resulted in stitches to the area near the base of the thumb.No product defects or failures were found.A review of product labeling determined that instructions were adequate with regard to the operation and safety instructions of the symbia s system.The patient injury was the result of user error.The operator was using the hand controller to manually move the patient bed and did not ensure that the patient kept all body parts out of the way of the moving table.No operator injury occurred.Customer narrative: "after the exam, the technologist used the hand controller to move the table away from the gantry horizontally.During this movement the patient.During on pallet supine feet facing the gantry, moved their left hand and placed it behind their back, sustaining a shallow cut to their left hand.".

• Brand Name: SYMBIA S
• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 north barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 north barrington rd.; hoffman estates, IL 60192 ; 8473046022
• MDR Report Key: 4925821
• MDR Text Key: 6030321
• Report Number: 1423253-2015-00006
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08717741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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): Other
• Patient Age: 80 YR