FDA Adverse Event Summary report: N

HARMONY LED585 SURGICAL LIGHT

MDR report key: 4871328 · Received June 26, 2015

Report

Report Number: 1043572-2015-00063
Date Received: June 26, 2015
Date of Event: May 27, 2015
Report Date: June 26, 2015
Manufacturer: STERIS CORPORATION - MONTGOMERY
Product Code: FSY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL LIGHT AND CONFIRMED THE SURGICAL LIGHT SHOWED SIGNS OF RUST AND PAINT CHIPPING. THE TECHNICIAN REMOVED ANY LOOSE PAINT, LIGHTLY SANDED THE RUST SPOTS AND APPLIED PAINT. THE SURGICAL LIGHT WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE RUST AND PAINT CHIPPING ON THE SURGICAL LIGHT IS INDICATIVE OF IMPROPER CLEANING PROCEDURES BY USER FACILITY PERSONNEL. THE STERIS ACCOUNT MANAGER IS WORKING WITH USER FACILITY PERSONNEL TO PERFORM IN-SERVICE TRAINING ON PROPER CLEANING PROCEDURES AS STATED IN SECTION 6 OF THE OPERATOR MANUAL. STERIS IS FILING THIS REPORT AS WE ARE UNABLE TO CONFIRM WITH THE USER FACILITY IF THE STERILE FIELD WAS COMPROMISED DUE TO THE REPORTED EVENT.

Description of Event or Problem · 1

THE USER FACILITY REPORTED RUST AT THE COLLAR OF THEIR HARMONY LED585 LIGHTHEAD. NO REPORT OF INJURY OR PROCEDURAL DELAYS OR CANCELLATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414917	HARMONY LED585 SURGICAL LIGHT	SURGICAL LIGHT	FSY	STERIS CORPORATION - MONTGOMERY

Patients

Seq	Age	Sex	Outcome	Treatment
1