MalfunctionLRO
CENTURION SURGICAL PROCEDURE PAK
Received Jul 22, 2026 · Event occurred Jun 22, 2026
Report 9681121-2026-00209 · MDR key 25902292
Device
Generic name
General Surgery Tray (kit)
Manufacturer
Pt. Ciba Vision BatamModel number
NACatalog number
8065000159
Lot number
31614040
Product problems
- Incomplete or Inadequate Connection
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT LOOSE TIP MESSAGE DISPLAYED DURING CALIBRATION. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT AT THE TIME OF REPORTING.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (b)(4)