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 not returned for evaluation.The lot number is unknown.Bleeding 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
The site reported when withdrawing the gencut core biopsy needle, a gush of blood was noticed in the aspiration syringe.The procedure was aborted as it was complicated by massive bleeding." no further information is known at this time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6607539
• Report Number: 3004962788-2017-05058
• Device Sequence Number: 10764997
• Product Code: EOQ
• UDI-Device Identifier: 10884521539716
• UDI-Public: 10884521539716
• Combination Product (Y/N): N
• PMA/510(K) Number: K142839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: SDCT01
• Device Catalogue Number: SDCT01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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: Other
• Patient Age: 62 YR