SURGICAL SUCKER/ SUMP SET
Received Nov 19, 2014 · Event occurred Nov 5, 2014
Report 1625519-2014-00001 · MDR key 4392400
Device
Generic name
Adult Hex Handle Grooved - Tip Sucke
Manufacturer
Novosci Corp.Model number
201135NSLot number
295044/294810
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
PICTURES OF THE DEVICE WERE SENT. ONLY PARTIAL PIECE OF SUCKER IN PICTURES. INITIAL INVESTIGATION SHOWS THAT THE BONDING AGENT SEEMED TO HAVE WORKED PROPERLY. THE FAILURE POINT FOR THE DEVICE WAS THE TIP/SUCKER CONNECTION. THIS IS A NATURAL FLEX POINT FOR THIS DEVICE. BASED ON THE PICTURES THE FAILURE SEEMS TO BE THE RESULT OF TOO MUCH FORCE BEING APPLIED TO THE TIP OF SUCKER CAUSING A BREAK. A DIRECTION FOR USE IS INCLUDED FOR THE SUCKER/SUMP SETS. IT DIRECTS THAT CARE SHOULD BE USED WHEN APPLYING FORCE TO THE SUCKER. ANY EXCESSIVE FORCE OR IMPROPER USE COULD CAUSE THE TIP TO BREAK. (B)(4).
Description of Event or Problem
ON (B)(6) 2014 AN INCIDENT WAS REPORTED TO NOVOSCI BY THE DISTRIBUTOR MEDTRONIC. FROM THEIR REPORTS, DURING AN OPERATION THE TIP OF A TMP SUCKER CAME UNATTACHED DURING THE USE IN A SURGERY. IT WAS UNCERTAIN IF THE DEVICE WAS BROKEN WHILE IN THE PATIENTS CHEST. THE PRODUCT WAS PARTIALLY SAVED AND PICTURES WERE TAKEN FOR INVESTIGATION PURPOSES. THE PERFUSIONIST STATED THAT THERE WAS NO INJURY TO PATIENT DUE TO THE INCIDENT. A INVESTIGATION WILL FOLLOW.