MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; ACCELERATOR, LINEAR, MEDICAL

Model Number	SDM3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation therefore no evaluation could be completed.The lot number was not provided therefore the dhr could not be reviewed.Though there was no device issue superdimension is filing this mdr out of an abundance of caution, due to the additional risk associated with the repeat procedure.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the fiducial was left behind in patient after the video-assisted thoracoscopic surgery.The physician was not aware the fiducial marker was an implantable device and took the patient back the next day to retrieved the fiducial.The event extend patient¿s hospitalization.There was no report of patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 6861373
• Report Number: 3004962788-2017-05090
• Device Sequence Number: 718033
• Product Code: IYE
• UDI-Device Identifier: 10884521198807
• UDI-Public: 10884521198807
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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: Health Professional
• Device Model Number: SDM3
• Device Catalogue Number: SDM3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR