MAUDE Adverse Event Report: SUPERDIMENSION INC. GENCUT CORE BIOPSY SYSTEM

Model Number	SDCT01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.There were no anomalies identified during the internal review of the dhr for the gencut core biopsy system.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.
Event or Problem Description
A patient received a left iatrogenic pneumothorax during a superdimension enb procedure.Patient had post-op sob & chest pain.The initial chest x-ray showed small 10% pneumothorax and it progressed to 50%.A chest tube was inserted and the patient was admitted for observation.The chest tube was removed on (b)(6) 2016 & the patient was discharged to home on (b)(6) 2016.

• Brand Name: GENCUT CORE BIOPSY SYSTEM
• Common Device Name: GENCUT CORE BIOPSY SYSTEM
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• MDR Report Key: 5962717
• Report Number: 3004962788-2016-00247
• Device Sequence Number: 10905204
• Product Code: EOQ
• UDI-Device Identifier: 10884521539716
• UDI-Public: 10884521539716
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K142839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2016

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: SDCT01
• Device Catalogue Number: SDCT01
• Device Lot Number: GC00084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) SUPERDIMENSION INREACH SYSTEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR