MAUDE Adverse Event Report: COOK IRELAND LTD. ECHO TIP ULTRA EBUS NEEDLE; BIOPSY NEEDLE

Model Number	G52011
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having an ebus procedure done in the operating room under general anesthesia, intubated.Several passes had been done on the same lymph node using the ebus needle.With the last pass using this needle, removal of the needle through the scope met much resistance.Assisting rt withdrew the needle and upon examination it appeared that part of the needle had broken off.Physician used the bronchoscope to examine all areas that are visible using the scope and no needle was observed.Procedure was continued using another needle and other instruments including fluoroscopy.Physician had the tech do a full fluoro scan of the lungs and no needle was observed.There was no bleeding upon completion of the procedure.After extubation and while in recovery, the patient was coughing up blood tinged sputum.Pacu rn noted a metal object on his lip.Pulmonologist and anesthesia aware.Repeat cxr completed- no needle noted.Fair level of confidence that remainder of needle was coughed out.Fda safety report id # (b)(4).

• Brand Name: ECHO TIP ULTRA EBUS NEEDLE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD.
• MDR Report Key: 13966173
• Report Number: MW5108643
• Device Sequence Number: 4271364
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)241202(10)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

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 Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1892766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2022
• 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: EBUS BRONCHOSCOPE (MODEL: BF-UC180F)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White