FDA Adverse Event Malfunction Summary report: N

ENTREE CEILING MOUNT MICROSCOPE SYSTEM

MDR report key: 432318 · Received December 6, 2002

Report

Report Number
1937051-2002-00003
Event Type
Malfunction
Date Received
December 6, 2002
Date of Event
November 9, 2002
Report Date
December 6, 2002
Manufacturer
GLOBAL SURGICAL CORP.
Product Code
EPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THREE RETAINING SCREWS ON A WALL MOUNTED MICROSCOPE HAD BEGUN TO LOOSEN, PRESENTING A POTENTIAL DANGER THAT AT SOME POINT THE MICROSCOPE COULD FALL FROM THE MOUNT. A COMPLETE FAILURE DID NOT OCCUR AND THERE WERE NO INJURIES REPORTED AS A RESULT. AN EVALUATION OF THE PRODUCT DRAWINGS AND DESIGN SPECIFICATIONS INDICATED THAT WHEN PROPERLY INSTALLED, THERE WOULD BE NO POSSIBLE WAY FOR THE UNIT TO FALL FROM THE BRACKET. HOWEVER, DURING THE INITIAL INSTALLATION, THE COLUMN-MOUNTING BRACKET WAS INVERTED. IN THIS POSITION, THE THREE RETAINING SCREWS WERE SUBJECTED TO STRESS FOR WHICH THEY WERE NEVER DESIGNED TO WITHSTAND. THE FIELD REPRESENTATIVE WAS NOTIFIED TO CORRECTLY REPOSITION THE COLUMN SHAFT IN THE SUPPORT BRACKET. IN ADDITION, A LISTING OF ACCOUNTS WHO HAD PURCHASED THIS PARTICULAR WALL MOUNT WAS MADE AVAILABLE TO AREA REPRESENTATIVES REQUESTING THEM TO REVIEW THEIR ACCOUNTS TO DETERMINE IF THIS CONDITION MIGHT EXIST WITH OTHER INSTALLATIONS. ONCE IDENTIFIED, EACH SITUATION WILL BE EVALUATED AND CORRECTED BY EITHER REPOSITIONING THE INVERTED BRACKET OR BY DRILLING AND INSTALLING A SAFETY BOLT THROUGH THE POST AND COLUMN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENTREE CEILING MOUNT MICROSCOPE SYSTEM DENTAL MICROSCOPE EPT GLOBAL SURGICAL CORP. M 705WK NA

Patients

Seq Age Sex Outcome Treatment
1 NA