FDA Adverse Event
Malfunction
Summary report: N
LITHOVUE
MDR report key: 19833788
·
Received July 25, 2024
Report
- Report Number
- 2124215-2024-41898
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- July 5, 2024
- Report Date
- July 25, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGB
- UDI-DI
- 08714729874522
- PMA / PMN Number
- K153049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IMPACT CODE A090206 IS SELECTED TO REPRESENT THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING THE PREPARATION, TWO LITHOVUE FLEXSCOPES WERE USED AND PLUGGED INTO THE MONITOR AND "HARDWARE MALFUNCTION" USER MESSAGE KEPT ON APPEARING ON THE MONITOR SCREEN. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187088 | LITHOVUE | URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FGB | BOSTON SCIENTIFIC CORPORATION | M0067911000 | BLV3157 | 08714729874522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |