CALIPER IN & OUT DIA TO 150MM
Received Mar 8, 2019
Report 9610612-2019-00171 · MDR key 8404048
Device
Generic name
General Surgical Instruments
Manufacturer
Aesculap AgModel number
AA846RCatalog number
AA846R
Product problems
- Component Missing
- Component Missing
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. THE TWO CALIPERS ARE IN A MINT CONDITION, BUT TWO ADJUSTMENTS SCREWS AND ONE GUIDING SCREW ARE NOT IN PLACE. ONLY ONE OF THE ADJUSTMENT SCREWS WAS PROVIDED, THE OTHER ADJUSTMENT SCREW AND THE GUIDING SCREW ARE MISSING. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. A CALIPER "A" ONE OF THE ADJUSTMENT SCREWS IS NOT IN PLACE. AT CALIPER "B" ONE OF THE ADJUSTMENT SCREWS AND GUIDING SCREW ARE NOT IN PLACE. IT IS NO LONGER TRACEABLE FROM TO WHICH CALIPER THE PROVIDED SCREW BELONGS TO. A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE.
Description of Event or Problem
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "THE SCREW WAS LOOSE AND THIS MADE IS IMPOSSIBLE TO USE THE CALIPER."