HANDPIECE BOX OF 10

Additional Manufacturer Narrative

COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REF E-COMPLAINT-(B)(4).

Description of Event or Problem

"THE CAUTERY FAILED DURING LEEP PROCEDURE." REF E-COMPLAINT-(B)(4).

Additional Manufacturer Narrative

REF (B)(4). INVESTIGATION: NO SAMPLE RETURNED, REVIEW DHR. ANALYSIS AND FINDINGS: IT HAS BEEN APPROXIMATELY 65 DAYS AND THE REPORTED SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATIVE ANALYSIS. THE HANDPIECE IS PURCHASED FROM AND POUCHED BY A SUPPLIER. THE INDIVIDUAL POUCHES ARE PLACED INTO PACKAGING AT COOPERSURGICAL. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO COMPLAINTS FOR THIS ISSUE. A REVIEW OF THE DHR (171329) DID NOT SHOW ANY ABNORMALITIES. THE PRODUCT WAS PACKAGED AT COOPERSURGICAL IN FEBRUARY 2016. LOT 037886 HAS BEEN DEPLETED FROM FINISHED GOODS INVENTORY. THE REPORTED COMPLAINT COULD NOT BE VERIFIED OR CONFIRMED DUE TO THE AFFECTED SAMPLE NOT BEING RETURNED FOR INVESTIGATIVE ANALYSIS. BASED ON THE INFORMATION FROM ABOVE, THE REPORTED COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT. CORRECTION AND/OR CORRECTIVE ACTION: NONE. REASON: NO FURTHER ACTION IS NEEDED AT THIS TIME. HOWEVER, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED SHOULD THE SAMPLES BE RETURNED. WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

Description of Event or Problem

"THE CAUTERY FAILED DURING LEEP PROCEDURE." REF (B)(4).