MAUDE Adverse Event Report: BUFFALO FILTER PLUMEPEN; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	ELITE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Red hair found in the sterile cautery holster on buffalo cautery pencil.Operation room set up had to be disassembled and a new pack opened.This was noted by staff and was taken down prior to reaching the patient.New device had to be opened.

• Brand Name: PLUMEPEN
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): BUFFALO FILTER; 5900 genesee st; lancaster NY 14086
• MDR Report Key: 8296613
• Report Number: 8296613
• Device Sequence Number: 14069123
• Product Code: GEI
• UDI-Device Identifier: 00815198012090
• UDI-Public: (01)00815198012090(17)210121(10)171283
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2019
• Report Date (Section F): 01/21/2019

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: No Information
• Device Model Number: ELITE
• Device Catalogue Number: PLP2001
• Device Lot Number: 171283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/21/2019