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

Model Number	ILS-2100-PN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter during the procedure, the devices had no defects and the physician was able to complete the case.The patient experienced pneumothorax and had to used chest tube.The event has lead to or extend patient hospitalization.
Additional Manufacturer Narrative
Pneumothorax 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.

• Brand Name: ARCPOINT
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 14887649
• Report Number: 3004962788-2022-00049
• Device Sequence Number: 12311144
• Product Code: EOQ
• UDI-Device Identifier: 10884521723610
• UDI-Public: 10884521723610
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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 Model Number: ILS-2100-PN
• Device Catalogue Number: ILS-2100-PN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female