FDA Adverse Event
Malfunction
Summary report: N
COREDX
MDR report key: 18418561
·
Received December 29, 2023
Report
- Report Number
- 3005099803-2023-06885
- Event Type
- Malfunction
- Date Received
- December 29, 2023
- Date of Event
- December 6, 2023
- Report Date
- December 29, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- UDI-DI
- 08714729971054
- PMA / PMN Number
- K183085
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILED TO CLOSE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE LUNGS DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE JAWS OF THE FORCEPS WAS UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1842162 | COREDX | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BOSTON SCIENTIFIC CORPORATION | M00515220 | 0027947752 | 08714729971054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |