FDA Adverse Event Malfunction Summary report: N

VISUM LED II SURGICAL LIGHT

MDR report key: 2479568 · Received February 23, 2012

Report

Report Number: 2031963-2012-00027
Event Type: Malfunction
Date Received: February 23, 2012
Date of Event: January 30, 2012
Report Date: January 30, 2012
Manufacturer: STRYKER COMMUNICATIONS
Product Code: FSY
PMA / PMN Number: K060802
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DATA EXISTS. THE CAMERA COVERS INVOLVED IN THIS REPORT WERE RETURNED FOR EVALUATION ON (B)(4) 2012. ADDITIONAL INVESTIGATION IS ONGOING. THE CATALOG NUMBER PROVIDED IS FOR THE IN-LIGHT CAMERA COVER WHICH IS THE COMPONENT IDENTIFIED AS ALLEGEDLY MALFUNCTIONING. EVALUATION SUMMARY: THE GLASS OF THE STERILIZABLE IN-LIGHT CAMERA COVERS WAS REPORTED TO HAVE FALLEN OUT OF THE COVER. THE CAMERA COVERS HAVE BEEN RETURNED TO THE MANUFACTURER AND VISUALLY EVALUATED. FURTHERMORE, A STRYKER ENGINEER VISITED A CUSTOMER ACCOUNT FOR ADDITIONAL EVALUATION REGARDING THE USE, CLEANING, AND STERILIZING OF THE CAMERA COVERS BUT NO CONCLUSION AS TO THE CAUSE OF THIS REPORTED EVENT CAN BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT OR CAREGIVER. THIS IS NOT A SINGLE USE DEVICE.

Description of Event or Problem · 1

(B)(4): IT WAS REPORTED THAT THE IN-LIGHT CAMERA COVERS ARE ALLEGEDLY "WARPING AND CAUSING THE GLASS TO FALL OUT." THE GLASS HAS REPORTEDLY NOT FALLEN DURING A CASE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT AND NO REPORTED ADVERSE CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VISUM LED II SURGICAL LIGHT		FSY	STRYKER COMMUNICATIONS

Patients

Seq	Age	Sex	Outcome	Treatment
1