inforMED
MalfunctionFSO

S7 CEILING MOUNT/RIGID COLUMN FOR OPMI PROERGO

Received Jan 11, 2013 · Event occurred Dec 18, 2012

Report 9615010-2013-00001 · MDR key 2918802

Device

Generic name

Microscope Surgical, General & Plastic...

Model number

S7 CEILING MOUNT

Catalog number

000000-1103-022

Product problems

  • Device Slipped

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE FIELD SERVICE REPRESENTATIVE DISCOVERED THE LOOSE SCREWS DURING A SERVICE VISIT. SHE SUBSEQUENTLY TIGHTENED THE LOOSE SCREWS TO SPECIFICATIONS. SITE CONTACT: (B)(6).

Description of Event or Problem

ALL FOUR OF THE SOCKET HEAD CAP SCREWS THAT SECURE THE S7 SUSPENSION SYSTEM CARRIER ARM WITH OPMI PROERGO DENTAL MICROSCOPE TO THE RIGID CEILING COLUMN MOUNT AT THE USER SITE WERE FOUND TO BE LOOSE.

Remedial action

  • Modification/Adjustment