MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER EXCELON¿; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00564101
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in a procedure performed on (b)(6) 2016.According to the complainant, the needle bends easily.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an excelontransbronchial aspiration needle was used in a procedure performed on (b)(6) 2016.According to the complainant, the needle bends easily.Additional information received on august 01, 2017.During the procedure it was noted that the needle easily bends.Additionally, the syringe didn't fit correctly and wouldn't fully screw on creating a poor vacuum.The procedure was completed with another of the same device and there was ¿no damage to the patient¿.

• Brand Name: EXCELON¿
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6722861
• Report Number: 3005099803-2017-02078
• Device Sequence Number: 19216970
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: (01)08714729456452(17)20190228(10)18920495
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: 02/28/2019
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 18920495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1