MalfunctionDTS
SURGICAL SUCKER/ SUMP SET
Received Nov 19, 2014 · Event occurred Nov 5, 2014
Report 1625519-2014-00002 · MDR key 4392401
Device
Generic name
Adult Hex Handle Grooved - Tip Sucke
Manufacturer
Novosci Corp.Model number
201135NLot number
295004/ 294810
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
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 USE IN A SURGERY. IT WAS UNCERTAIN IF IT WAS BROKEN WHILE IN PATIENTS CHEST. THE PRODUCT WAS DISCARDED AND NOT AVAILABLE FOR RETURN. THE PERFUSIONIST STATED THAT THERE WAS NO INJURY TO PATIENT DUE TO THE INCIDENT.
Additional Manufacturer Narrative
DEVICE WAS DISCARDED AFTER SURGERY. WE ARE WAITING ON ADDITIONAL INFO FROM USER. (B)(4).