| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS RHINO-LARYNGOFIBERSCOPE | RHINO-LARYNGOFIBERSCOPE | OLYMPUS MEDICAL SYSTEMS CORPORATION | CAL | ENF-P4 | NA | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-04-25 | 0 |
Patient 1
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING NASAL ENDOSCOPY, THE DOCTOR FELT THAT IT WAS DIFFICULT TO WITHDRAW THE SUBJECT DEVICE FROM THE PT, BUT THE DOCTOR REMOVED IT WITH STRONG FORCE AND CONSEQUENTLY, THE PT HAD A SLIGHT BLOODY NOSE TEMPORARILY. AFTER REMOVING IT FROM THE PT, THE DOCTOR FOUND THAT A METAL PART WAS EXPOSED DUE TO A SPLIT ON THE INSERTION TUBE.
Patient 1
BASED ON THE EVAL OF THE SUBJECT DEVICE BY OMSC, IT WAS CONFIRMED THAT THE INSERTION TUBE WAS SPLIT AND THERE WERE SCRATCHES AND INDENTATION MARKS NEAR THE SPLIT PART. BASED ON THE ABOVE RESULT, IT IS CONSIDERED THAT SINCE THE USER CONTINUED TO USE THE DEVICE WHILE THERE WERE SCRATCHES AND INDENTATION IN THE INSERTION TUBE, THE SCRATCHES AND INDENTATION GREW BIGGER AND IT FINALLY TORE THE INSERTION TUBE. IT IS POSSIBLE THAT THE SCRATCHES AND INDENTATION WERE CAUSED BY WITHDRAWING THE INSERTION TUBE FORCIBLY OR HITTING THE INSERTION TUBE WITH A HARD OBJECT. THE INSTRUCTION MANUAL OF ENF-P4 MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. BASED ON THE FINDINGS, INAPPROPRIATE HANDLING BY THE USER COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR OF THE EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.