FDA Adverse Event Injury Summary report: N

GOLDVAC SLIM,PUSH BUTTON,10FT

MDR report key: 7651972 · Received June 29, 2018

Report

Report Number: 3007216334-2018-00166
Event Type: Injury
Date Received: June 29, 2018
Date of Event: January 22, 2018
Report Date: June 29, 2018
Manufacturer: BUFFALO FILTER LLC
Product Code: GEI
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DISTRIBUTOR NARRATIVE: THE MANUFACTURE, BUFFALO FILTER LLC, HAS BEEN NOTIFIED AND IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION.

Description of Event or Problem · 1

THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT, DURING A PROCEDURE, THE TIP OF THE 60-7610-001 BROKE. PART OF THE BROKEN DEVICE WAS FOUND AMONG THE SURGICAL DRAPES; HOWEVER, A PIECE 0.2MM X 0.4MM WAS NOT FOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED DELAYS. NO PATIENT INJURY WAS REPORTED. UPON ATTEMPTS TO GATHER ADDITIONAL INFORMATION, NO INFORMATION REGARDING CURRENT PATIENT STATUS OR PROCEDURE IS AVAILABLE. A VOLUNTARY DISTRIBUTOR REPORT IS BEING RAISED ON THE BASIS OF THE UNKNOWN LOCATION OF A NON-IMPLANTABLE PIECE OF A DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
492726	GOLDVAC SLIM,PUSH BUTTON,10FT	GOLDVAC PENCILS	GEI	BUFFALO FILTER LLC		170803

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other