| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-09 | 0 |
Patient 1
(B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DOUBLE AIR-HOSE DEVICE WAS LEAKING. IT WAS REPORTED THAT THE SAME EVENT OCCURRED WITH THREE HOSE DEVICES IN THE SAME PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient 1
ADDITIONAL INFORMATION: THE INITIAL MEDWATCH REPORT STATED THAT THREE PRODUCTS WERE INVOLVED IN THE SAME EVENT. DURING SUBSEQUENT FOLLOW-UP WITH THE REPORTER, ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTER STATED THAT THERE WERE FOUR PRODUCTS USED IN THE SAME PROCEDURE. THEREFORE, THIS REPORT REPRESENTS 2 OF 4 PRODUCTS FOR THE SAME EVENT. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION OF AN AIR HOSE LEAK WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH DETERMINED THE UNIT WAS GENERALLY BROKEN, TORN OFF. IT WAS NOTED THAT THE DEVICE WAS PHYSICALLY BROKEN. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.