inforMED
MalfunctionFAT

INFRAVISION URETERAL KIT

Received May 9, 2011 · Event occurred Apr 11, 2011

Report 2936485-2011-00300 · MDR key 2133222

Device

Generic name

Catheter

Catalog number

0220180516

Lot number

PSTR091609-1

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

UNK

  • No Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE UNIT WAS NOT VERY VISIBLE THROUGH THE WALL OF THE URETHRA. IT WAS FURTHER REPORTED BY THE SURGEON THAT HE NORMALLY HAS A BETTER VIEW AND THE ENTIRE URETHRA IS LIT UP.

Additional Manufacturer Narrative

ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.