FDA Adverse Event Malfunction Summary report: N

SPRING ARM & YOKE, FLAT PANEL

MDR report key: 3180028 · Received June 20, 2013

Report

Report Number: 0002031963-2013-00038
Event Type: Malfunction
Date Received: June 20, 2013
Date of Event: May 23, 2013
Report Date: May 23, 2013
Manufacturer: STRYKER-COMMUNICATIONS
Product Code: FSY
PMA / PMN Number: K031068
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE FLAT PANEL MONITOR YOKE REPORTEDLY SEPARATED FROM THE SPRING ARM OF THE CEILING MOUNTED VISUM HALOGEN LIGHT SURGICAL LIGHT SYSTEM. UPON EVALUATION BY A STRYKER FIELD SERVICE REPRESENTATIVE, IT WAS OBSERVED THAT THE M3 SCREW AND THE KEEPER CLIP WERE MISSING FROM THE SPRING ARM ASSEMBLY. THE M3 SCREW KEEPS THE SPRING ARM'S SAFETY COLLAR IN PLACE, WHICH IS USED IN ORDER TO PREVENT THE KEEPER CLIP, A SEMICIRCULAR METAL DISK, FROM BECOMING SEPARATED FROM THE SPRING ARM; THEREBY SERVING TO KEEP THE FLAT PANEL ATTACHED TO THE SUSPENSION. WITH THE M3 SCREW MISSING, THE SAFETY COLLAR LIKELY SLID OUT OF POSITION ALLOWING THE KEEPER CLIP TO COME LOOSE RESULTING IN THE FLAT PANEL YOKE DETACHING FROM THE SPRING ARM. IT COULD NOT BE DETERMINED HOW THE SCREW CAME TO BE MISSING, BUT IT IS LIKELY IT WAS REMOVED FOR ANOTHER PURPOSE BY A THIRD PARTY OR BY THE A HOSPITAL STAFF MEMBER AND NOT REINSTALLED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FLAT PANEL MONITOR YOKE HAD SEPARATED FROM THE SPRING ARM OF THE CEILING MOUNTED VISUM HALOGEN LIGHT SURGICAL LIGHT SYSTEM. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281568	SPRING ARM & YOKE, FLAT PANEL	VISUM HALOGEN SURGICAL LIGHT	FSY	STRYKER-COMMUNICATIONS

Patients

Seq	Age	Sex	Outcome	Treatment
1