INFRAVISION URETRAL KIT
Received Sep 4, 2012 · Event occurred Aug 8, 2012
Report 2936485-2012-00475 · MDR key 2748095
Device
Generic name
Uretral Kit
Manufacturer
Stryker Endoscopy San JoseCatalog number
0220180516
Lot number
PSTR1167-11
Product problems
- Optical Problem
Patient
UNK
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED THAT CATHETERS BLINK ONLY AT THE DISTAL END. THE PROCEDURE WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY. THE PATIENT BEGAN TO BLEED AS THE UNIT WAS BEING INSERTED INTO THE URETER AND WAS NOTICED DURING THE FIRST INSERTION. IT WAS FURTHER REPORTED THAT A NEW CATHETER WAS USED AND IT FUNCTIONED PROPERLY.
Additional Manufacturer Narrative
A QUANTITY OF TWO UNITS, SAME PART AND LOT NUMBER, WERE IMPLICATED IN THIS EVENT. PLEASE REFER TO MEDWATCH REPORT NUMBER 2936485-2012-00474 FOR UNIT #1. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.