MalfunctionDWZ
MAXXIM MEDICAL BIOPSY FORCEP "JAWS"
Received May 16, 2002
Report 1625425-2002-00007 · MDR key 395531
Device
Generic name
Biopsy Forcep
Manufacturer
Maxxim MedicalModel number
*Catalog number
190031
Lot number
020247
Product problems
- Difficult to Remove
- Sticking
Patient
*
- Dural Tear
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
THE DOCTOR MADE TWO SUCCESSFUL PASSES WITH THIS FORCEP. JUGULAR APPROACH GOT TWO SUCCESSFUL SAMPLES. THIRD INTO RIGHT VENTRICLE. THROUGH THE VALVE, OPENED WITH NO PROBLEM. FORCEP TIP AGAINST VENTRICLE WALL AND JAWS WOULD NOT OPEN. JAWS HAD ENGAGED SOME TISSUE AND THE PHYSICIAN TUGGED UNTIL THE JAW REMOVED ITSELF PEELED ENDOMYSCARDIAL TISSUE. PATHOLOGY CONFIRMED THAT IT WAS ENDO TISSUE AND NOT IN VALVE.