MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC CROSSCOUNTY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	SDATSW01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pleural Effusion (2010); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient had two weeks of breathlessness.It began on (b)(6) and continued until the 15th when the patient went to the hospital.The computed tomography (ct) showed 3cm pleural effusion, and saturation of 96% on room air.The patient was admitted for ultrasound guided airway and treatment of chronic obstructive pulmonary disease (copd) exacerbation.The ultrasound showed very small fluid, the small pleural effusion was determined to be probably related to the ablation procedure, because the ablation zone reached the lung surface, mil/or nil was aspirated.The patient was given antibiotics and steroids.The copd exacerbation was seen to be possibly related to the ablation procedure, but the patient normally gets that with hot weather and it happened 2 weeks after discharge, it was treated with antibiotics and steroids.The patient condition improved and was then discharged.The patient was hospitalized from (b)(6) 2020 - (b)(6) 2020.

• Brand Name: CROSSCOUNTY
• 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: 10399459
• Report Number: 3004962788-2020-00044
• Device Sequence Number: 2880658
• Product Code: EOQ
• UDI-Device Identifier: 10884521539723
• UDI-Public: 10884521539723
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2020
• Device Model Number: SDATSW01
• Device Catalogue Number: SDATSW01
• Device Lot Number: 511395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/12/2020
• 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; Required Intervention
• Patient Age: 81 YR