N/A 130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-01 for N/A 130 manufactured by Conmed Corporation.

Event Text Entries

[98762656]
Patient Sequence No: 1, Text Type: N, H10

[98762657] A cytology specimen was obtained using a bronchial brush and at the completion of the procedure, the surgical tech went to cut the brush off to send as a specimen when she discovered that the brush tip was missing. The bronchial brush was inspected prior to start of procedure and it was intact. The surgeon was notified and attempts were made to search for the brush on the patient's person as well as in the bronchial lavage specimen but it was not found.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7233591
• MDR Report Key: 7233591
• Date Received: 2018-02-01
• Date of Report: 2018-01-26
• Date of Event: 2018-01-25
• Report Date: 2018-01-26
• Date Reported to FDA: 2018-01-26
• Date Reported to Mfgr: 2018-01-26
• Date Added to Maude: 2018-02-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N/A
• Generic Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Product Code: BTG
• Date Received: 2018-02-01
• Model Number: 130
• Catalog Number: 130
• Lot Number: 201709274
• ID Number: DISPOSABLE MICROBIOLOGY BRUSH
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 0 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONMED CORPORATION
• Manufacturer Address: 525 FRENCH ROAD UTICA NY 135025994 US 135025994

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-02-01