GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
Received Feb 1, 2021
Report 1519132-2021-00003 · MDR key 11261542
Device
Generic name
Gyn Operative 12 Degree 2.7mm Long Autoclavable
Manufacturer
Gyrus Acmi, IncModel number
G27L-12AProduct problems
- Break
- Defective Device
- Break
- Defective Device
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. PER THE LEGAL MANUFACTURER, THERE IS NO POTENTIAL FOR THIS ISSUE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Additional Manufacturer Narrative
DEVICE WAS EVALUATED. INSPECTION OF THE DEVICE CONFIRMED THE REPORTED ISSUE. DEVICE WAS FOUND WITH FRACTURED INTERNAL LENS. INVESTIGATION IS ONGOING THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH FRACTURED INTERNAL LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.