MalfunctionQRY
X-GUIDE SURGICAL NAVIGATION SYSTEM
Received Nov 13, 2024 · Event occurred Nov 8, 2024
Report 3011764595-2024-00001 · MDR key 20673512
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
50 YR · Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
OFFICE CALLED AND SAID SOMETHING "SNAPPED" IN ONE THE HINGES WITHIN THE BOOM ARM DURING SURGERY AND THE NAVIGATION ASSEMBLY PARTIALLY DROPPED AND HIT THE DOCTOR. DOCTOR IS PHYSICALLY OKAY. OFFICE WILL CALL BACK WHEN THE MACHINE IS AVAILABLE TO TAKE PICTURES AND ASSESS THE DAMAGE, SO TECHNICAL SUPPORT CAN DETERMINE HOW TO MOVE FORWARD WITH THE REPAIR. CAMERAS AND LIGHTS ARE STILL FUNCTIONAL. PATIENT WAS NOT INVOLVED.
Additional Manufacturer Narrative
DEVICE CURRENTLY UNUSABLE AT DOCTOR'S OFFICE, PENDING SERVICE AND RETURN OF PART TO HEADQUARTERS.