inforMED
MalfunctionKQM

TV-3 HANDLE CAMERA AURORA 3 AND FOUR SERIES

Received Jun 11, 2026 · Event occurred Jun 5, 2026

Report 25470602 · MDR key 25470602

Device

Generic name

Camera, Surgical And Accessories

Manufacturer

Skytron Llc

Model number

B1-715-56 AUA

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SKYTRON INLIGHT CAMERA UNEXPECTEDLY FELL OUT OF THE LIGHTHEAD DURING SURGICAL CASE WHEN SURGEON WAS ADJUSTING THE LIGHT. CAMERA DID NOT FALL ON ANY STAFF OR PATIENT. BIOMED INVESTIGATED, DID NOT FIND ANY PHYSICAL ISSUES WITH EITHER LIGHT HEAD OR INLIGHT CAMERA. HOWEVER, THE COVER REMOVE AND CAMERA DISCONNECT BUTTONS ON THESE SKYTRON CAMERA HEADS ARE VERY SIMILAR IN SIZE AND LOCATION. BELIEVE SOMEONE HAD ACCIDENTALLY HIT THE DISCONNECT BUTTON INSTEAD OF COVER REMOVE BUTTON PREVIOUSLY, WHICH CAUSED CAMERA HEAD TO BE ONLY LOOSELY SECURED. THIS IS THE THIRD REPORTED INSTANCE OF CAMERA FALLING FROM LIGHTHEAD DURING SETUP OR MID-SURGICAL CASE AT [REDACTED] (WE HAVE HAD SKYTRON LIGHTS FOR ~6-9 MONTHS). MANUFACTURER RESPONSE FOR SURGICAL INLIGHT CAMERA, (BRAND NOT PROVIDED) (PER SITE REPORTER) PENDING RESPONSE; EMAIL SEND [REDACTED].