N
Patient 1
MAUDE MDR 6882164
- MDR report key
- 6882164
- Report number
- 6882164
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-09-13
- Date received
- 2017-09-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | N.A. | URETHROSCOPE | KARL STORZ GMBH & CO. KG | FBO | 27023FM | PT02 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-21 | 0 |
Event Narratives#
D
Patient 1
THE END OF THE FLEXIBLE GRASPING FORCEPS BROKE OFF INTO THE PATIENT'S BLADDER. WE REMOVED THE LONG END AND USED ANOTHER CYSTOSCOPE AND GRASPER TO LOOK FOR IT. DOCTOR LOOKED AND LOOKED FOR IT, FOUND IT ONCE BUT WAS UNABLE TO REMOVE IT. HE SAID THE PATIENT SHOULD PASS IT ON HIS OWN BECAUSE IT IS SMALLER THAN THE STONES THAT WERE COMING OUT. FROM OP REPORT: I USED A SMALL FLEXIBLE GRASPER THROUGH THE FLEXIBLE SCOPE BUT THAT GRASPER FAILED. THE GRASPER BROKE AND I WAS UNABLE TO RETRIEVE IT WITHOUT REMOVING THE FLEXIBLE SCOPE. THEREFORE I REMOVED THE FLEXIBLE SCOPE AND USED A RIGID SCOPE AND PERFORMED CYSTOSCOPY. I WAS ABLE TO GRASP THE STENT EASILY WITH THAT AND REMOVE STENT. I THEN INSPECTED THE FLEXIBLE SCOPE AND I NOTED THAT A TINY PIECE OF THE FLEXIBLE GRASPER WAS NOT PRESENT ON THE GRASPING DEVICE. I PRESUMED THAT THIS SMALL PIECE WHICH WAS ONLY 1 MM IN LENGTH AND LESS THAN A MILLIMETER IN WIDTH WAS STILL IN THE PATIENT'S BLADDER. I INSPECTED THE BLADDER AND WAS ABLE TO FIND THIS MISSING PIECE WHICH IS VERY SMALL. IF IT IS IN HIS BLADDER IT SHOULD BE SMALL ENOUGH TO PASS AS IT IS SMALLER THAN THE FRAGMENTS THAT WE EXPECTED PASS WITH THE LITHOTRIPSY.