FDA Adverse Event
Malfunction
Summary report: N
EXALT MODEL D SINGLE-USE DUODENOSCOPE
MDR report key: 19052905
·
Received April 5, 2024
Report
- Report Number
- 3005099803-2024-01255
- Event Type
- Malfunction
- Date Received
- April 5, 2024
- Date of Event
- March 18, 2024
- Report Date
- April 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDT
- UDI-DI
- 08714729993605
- PMA / PMN Number
- K193202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6 (DEVICE CODES): PROBLEM CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE INSIDE THE PATIENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN EXALT MODEL D SINGLE USE DUODENOSCOPE WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS A BLUE CIRCLE IN THE SCREEN BLOCKING THE VISIBILITY. A SECOND EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1758090 | EXALT MODEL D SINGLE-USE DUODENOSCOPE | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDT | BOSTON SCIENTIFIC CORPORATION | M0054242CE1 | 0031767053 | 08714729993605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |