FDA Adverse Event Injury Summary report: N

HARMONY LA500 LIGHT

MDR report key: 1850534 · Received October 1, 2010

Report

Report Number: 1043572-2010-00070
Event Type: Injury
Date Received: October 1, 2010
Date of Event: September 7, 2010
Report Date: October 1, 2010
Manufacturer: STERIS CORPORATION - MONTGOMERY
Product Code: FTD
PMA / PMN Number: K013242
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL LIGHT AND FOUND THAT THE SECTION OF THE LIGHTHEAD COVER THAT FELL WAS CRACKED; THIS CRACK ALLOWED THE COVER TO SEPARATE FROM THE SCREW HOLDING IT IN PLACE SUBSEQUENTLY ALLOWING THE SECTION OF THE LIGHTHEAD COVER TO FALL. THE SURGICAL LIGHT IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. THE CAUSE OF THIS EVENT APPEARS TO BE LACK OF PROPER PREVENTATIVE MAINTENANCE. THE PREVENTATIVE MAINTENANCE SCHEDULE IN THE OPERATOR MANUAL STATES AT EACH INSPECTION (B)(4) "INSPECT PLUG BUTTONS, FASTENERS, COVERS, OR OTHER COMPONENTS THAT MAY ATTACH TO THE CAMERA OR ARM OR SYSTEM ARM COMPONENTS". STERIS OFFERED TO CONDUCT IN-SERVICE TRAINING REGARDING THE PROPER MAINTENANCE OF THE EQUIPMENT HOWEVER THE USER FACILITY DECLINED.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT A SECTION OF SURGICAL LIGHT COVER FELL ONTO A PATIENT DURING A PROCEDURE. HOSPITAL PERSONNEL FLUSHED THE PATIENT SITE WITH ANTIBIOTIC SOLUTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS A PRECAUTION, THE PATIENT WAS PRESCRIBED ANTIBIOTICS; NO INJURIES WERE REPORTED. THE USER FACILITY REPORTS THAT THE PATIENT HAS SINCE BEEN DISCHARGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HARMONY LA500 LIGHT	HARMONY SURGICAL LIGHT	FTD	STERIS CORPORATION - MONTGOMERY

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other