PKG, 5MM PEEK MONOPOLAR HANDLE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

Description of Event or Problem

IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: IT WAS REPORTED BY THE CUSTOMER THAT THE LAPAROSCOPIC GRASPING FORCEPS HAD THE BLACK INSULATION PEEL OFF INSIDE THE PATIENT. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE COULD BE GOUGING OR SCRAPING OF THE INSULATION MATERIAL, WHICH MAY HAVE OCCURRED DURING USE AND/OR STERILIZATION CAUSING THE MATERIAL TO BEGIN TO PEEL. THE LOT NUMBER IS UNKNOWN, THEREFORE THE MANUFACTURE DATE CANNOT BE CONFIRMED.