PENTAX

Additional Manufacturer Narrative

(B)(4). THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDRS FOR COMPLAINTS/EVENTS OUTSIDE OF THE US (OUS). AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF ALL OUS EVENTS/COMPLAINTS RECEIVED SINCE OCTOBER 2015. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (B)(4). (EXEMPTION NUMBER E2015036).

Description of Event or Problem

PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED OUTSIDE THE USA STATING DURING ENDSOCOPY ACT, OF-B53 SPLASHING OUT LIQUID INFECTION ON MEDICAL AND NON-MEDICAL STAFF.

Additional Manufacturer Narrative

9610877-2016-00150 IS BEING SUBMITTED FOR THE FIRST VALVE; 9610877-2016-00151 IS BEING SUBMITTED FOR THE SECOND VALVE. (B)(4). EXEMPTION NUMBER E2015036.

Description of Event or Problem

THE FACILITY REPORTED THE EVENT TO (B)(6). PER PENTAX EUROPE, THE FACILITY STATED THE SUCTION VALVE GOT DISCONNECTED DURING THE PROCEDURE, AND LIQUID WAS SPLASHING OUT AND ONTO THE STAFF. THIS OCCURRED WITH 2 DIFFERENT VALVES AND 2 DIFFERENT SCOPES. PENTAX EUROPE STATED THE BRONCHOSCOPES DID NOT CONTRIBUTE TO THE EVENTS. IN ADDITION, THE IFU REQUESTS ANY USER TO WEAR PROTECTIVE GARMENT. THE SUCTION VALVE MENTIONED IN THIS REPORT WAS DISPOSED BY THE FACILITY, THEREFORE NO INVESTIGATION COULD BE PERFORMED ON THE VALVE. LOT NUMBERS WERE PROVIDED FOR THE VALVES INVOLVED IN THE INCIDENT, HOWEVER A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED CONFIRMING IF THE SUCTION VALVES WERE MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WERE RELEASED ACCORDINGLY SINCE THE LOT NUMBERS PROVIDED ARE NOT RECOGNIZED AS VALID LOT NUMBERS AND DO NOT EXIST IN OUR MANUFACTURING DATABASE. ACCORDING TO PENTAX EUROPE, (B)(6) CLOSED THE FILE WITHOUT ANY REQUESTS. NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE PENTAX CONSIDERS THIS MEDWATCH REPORT CLOSED.