KARLIN RETRACTOR, CRANK FRAME BODY
Received Aug 21, 2025
Report 3007208013-2025-00040 · MDR key 22864595
Device
Generic name
Karlin Retractor
Manufacturer
Symmetry Surgical Inc.Model number
46-3191Lot number
2235193 SO416533
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED AND IS IN PROCESS OF BEING EVALUATED. THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
COMPLAINANT ALLEGES THAT THE DEVICE IS NOT WORKING PROPERLY, IT IS NOT CRANKING. THIS OCCURRED DURING A PATIENT PROCEDURE.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING AS INTENDED. THE RETRACTOR WAS CLEANED, STERILIZED, AND LUBRICATED AFTER WHICH IT FUNCTIONED CORRECTLY AS INTENDED. THE ROOT CAUSE WAS INSUFFICIENT MAINTENANCE, ESPECIALLY A LACK OF OR MINIMAL LUBRICATION AS OUTLINED IN THE DEVICES IFU. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.