FDA Adverse Event
Malfunction
Summary report: N
EXALT MODEL D SINGLE-USE DUODENOSCOPE
MDR report key: 18707170
·
Received February 14, 2024
Report
- Report Number
- 3005099803-2024-00508
- Event Type
- Malfunction
- Date Received
- February 14, 2024
- Date of Event
- February 5, 2024
- Report Date
- February 14, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDT
- UDI-DI
- 08714729993605
- PMA / PMN Number
- K193202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 EXALT D SINGLE USE SCOPE WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES ON (B)(6), 2024. DURING PROCEDURE, THE PHYSICIAN NOTED POOR QUALITY IMAGE IN THE FORM OF A HONEYCOMB EFFECT ON THE SCOPE'S LENS WHILE TRYING TO CANNULATE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL SCOPE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787427 | EXALT MODEL D SINGLE-USE DUODENOSCOPE | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDT | BOSTON SCIENTIFIC CORPORATION | M00542421 | 0031913149 | 08714729993605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |