PK BUTTON FRONT LOADING ELECTRODE
Received Oct 3, 2011 · Event occurred Mar 15, 2011
Report 9617070-2011-00009 · MDR key 2665975
Device
Generic name
Pk Button Front Loading Electrode
Manufacturer
Gyrus Medical Ltd.Model number
786500Catalog number
786500
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL. THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem
AFTER TWO TURP PROCEDURE WHILE USING THE PKS SUPERPULSE GENERATOR (SEE MEDWATCH NUMBER: 9617070-2011-00003) AND THE PK BUTTON FRONT LOADING ELECTRODE, UNEXPECTED BLEEDING OCCURRED AND REQUIRED RE-ADMISSION AND FOLLOW UP SURGERY. THE ELECTRODE WAS NOT SAVED, IT WAS DISCARDED BY THE FACILITY. WE RECEIVED AN EMAIL ON (B)(6) 2011 STATING THAT THE GENERATOR IS STILL NOT BEING RELEASED FROM RISK MANAGEMENT. (SEE MEDWATCH NUMBER: 9617070-2011-00010 FOR THE 2ND ELECTRODE).