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

Model Number	ILS-1800-PN
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the pulmonary needle was loose in the patient when it was being used to collect sample.The needle was loose in the patient and had to be retrieved.The case was completed.There was no injury to the patient.

• 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
• MDR Report Key: 12450951
• Report Number: 3004962788-2021-00074
• Device Sequence Number: 14298509
• Product Code: EOQ
• UDI-Device Identifier: 10884521723627
• UDI-Public: 10884521723627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: ILS-1800-PN
• Device Catalogue Number: ILS-1800-PN
• Device Lot Number: SD1119172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1