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 customer discarded the device and it was not returned for evaluation.Therefore no evaluation could be performed.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 a procedure.Immediately after the first pass of the device, there was arterial bleeding due to neovascularization of the necrotic tumor which was sliced, as well as platelet dysfunction caused by non steroidal anti-inflammatory medication.They turned the patient to the side and introduced epinephrine and iced saline.They also did occlusion with scope and suction.The bleeding stopped and the airway was cleared.The patient was transferred to post anesthesia care unit and extubated.They re-intubated 15 minutes later with hypercapnia and altered mental state.It was found that the patient had acute myocardial infarction.The course was prolonged in intensive care unit and developed pneumonia during re-intubation.Palliative care was care.There was no reported device issue.

• 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: 7267151
• Report Number: 3004962788-2018-00007
• Device Sequence Number: 1823968
• 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
• Device Lot Number: UNKNOWN
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR