MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC GENCUT CORE BIOPSY SYSTEM; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	SDCT01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and was not returned for evaluation.A review of the appropriate device history records of the superdimension console indicates this device was released meeting all quality specifications.Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the patient experienced excessive bleeding during the procedure.There was bleeding from the blood vessels next to inflammatory nodule.They turned patient on the side and occluded the airway with the bronchoscope.They introduced iced saline and epinephrine and the bleeding stopped after 15 minutes.They extubated the patient and discontinue intervention without issues.There was no issues with the system reported.The patient was asymptomatic at follow up.

• Brand Name: GENCUT CORE BIOPSY SYSTEM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 7266874
• Report Number: 3004962788-2018-00006
• Device Sequence Number: 1655826
• Product Code: EOQ
• UDI-Device Identifier: 10884521539716
• UDI-Public: 10884521539716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: SDCT01
• Device Catalogue Number: SDCT01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/13/2018
• 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: SUPERDIMENSION INREACH SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR