SURGICAL SUCKER/SUMP SET
Received Apr 11, 2011
Report 1625519-2011-00001 · MDR key 2092897
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2011, AN INCIDENT WAS REPORTED TO NOVOSCI CORP BY THE DISTRIBUTOR. DURING AN OPEN HEART PROCEDURE, THE TIP OF THE HEX GROOVED SUCKER BROKE AND THE TIP FELL INTO THE PT'S OPEN CHEST CAVITY. THE SURGICAL TEAM WAS ABLE TO COMPLETELY RETRIEVE THE TIP DURING THE PROCEDURE. POST-OPERATION, THE SITE STATED THAT THE PT IS FINE AND THERE WERE NO CLINICAL SEQUELAE AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE LOT INFO OF THE SUBJECT DEVICE WAS NOT PROVIDED TO NOVOSCI CORP. THE SUBJECT DEVICE WAS SENT TO NOVOSCI FOR EVAL IN (B)(4) 2011. DURING THE INVESTIGATION OF THE DEVICE, IT WAS NOTED THAT THE TIP BOND WAS INTACT AND MET THE PRODUCT SPEC. THE FAILURE WAS THE TIP/SUCKER INTERFACE WHICH IS A NATURAL FLEXING POINT FOR THE DEVICE. BASED ON THE RESULTS OF THE INVESTIGATION, THE FAILURE APPEARS TO BE THE RESULT OF TOO MUCH FORCE BEING APPLIED TO THE TIP OF THE SUCKER. BASED ON THE INITIAL INFO RECEIVED BY NOVOSCI CORP ON (B)(6) 2011, AN INITIAL DETERMINATION OF THIS EVENT WAS DETERMINED NOT TO REQUIRE A MEDIAL DEVICE REPORT. HOWEVER, BASED ON ADD'L INFO RECEIVED BY THE DISTRIBUTOR, THE INFO WAS REASSESSED AND IT WAS DETERMINED THAT AN MDR WAS REQUIRED TO BE SUBMITTED TO FDA. THE DIRECTIONS FOR USE (B)(4) FOR THE SURGICAL SUCKER/SUMP SET INCLUDES A PRECAUTION STATEMENT THAT CARE SHOULD BE EXERCISED WHEN APPLYING FORCE TO ANY SUCKER OR SUMP SET SINCE EXCESSIVE BENDING OF THE TUBE OR THE TIP COULD CAUSE BREAKAGE.