MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERTRAX BIOPSY FORCEPS; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	AKI00133-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no lot number was provided.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 small pneumothorax which showed up on x-ray after a superdimension enb biopsy procedure.The doctor admitted the patient overnight for observation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERTRAX BIOPSY FORCEPS
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 6587889
• Report Number: 3004962788-2017-05054
• Device Sequence Number: 369792
• Product Code: FCL
• UDI-Device Identifier: 10884521200487
• UDI-Public: 10884521200487
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K925392
• 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): 04/27/2017

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: AKI00133-01
• Device Catalogue Number: AKI00133-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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
• Patient Age: 40 YR
• Patient Weight: 46