D
Patient 1
UPON REMOVAL OF ERCP SCOPE, IT WAS NOTICED THAT TIP OF ERCP SCOPE WAS MISSING. MISSING PIECE WAS FOUND IN PATIENT'S MOUTH AND REMOVED SUCCESSFULLY.
MAUDE MDR 9792669
- MDR report key
- 9792669
- Report number
- 9792669
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-03
- Date received
- 2020-03-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | ENDOSCOPE AND/OR ACCESSORIES | FUJIFILM MEDICAL SYSTEMS U.S.A., INC | EOQ | ED-530XT | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-05 | 0 |
Event Narratives#
D
Patient 1
UPON REMOVAL OF ERCP SCOPE, IT WAS NOTICED THAT TIP OF ERCP SCOPE WAS MISSING. MISSING PIECE WAS FOUND IN PATIENT'S MOUTH AND REMOVED SUCCESSFULLY. PATIENT WAS UNDER ANESTHESIA AND TIP WAS MISSING WHEN SCOPE WAS REMOVED. MISSING PIECE WAS FOUND IN PATIENT'S MOUTH BY FINGER SWEEP PRIOR TO EXTUBATION. NO HARM TO PATIENT. NO FURTHER TREATMENT NEEDED. THE DEVICE WAS SENT BACK TO THE COMPANY. I HAVE NOT RECEIVED ANY INFORMATION REGARDING THE SCOPE. I DO NOT HAVE THE AGE OF THE DEVICE.