COREDX?
Report
- Report Number
- 3005099803-2025-03206
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 1, 2025
- Report Date
- November 18, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- UDI-DI
- 08714729971054
- PMA / PMN Number
- K183085
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE. BLOCK H2: BLOCK B5 HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2025.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE. BLOCK H11: THE RETURNED COREDX BIOPSY FORCEPS WAS ANALYZED, AND IT WAS FOUND DURING VISUAL AND MICROSCOPE INSPECTION THAT THE JACKET WAS KINKED, ALSO THE LINKS WERE DETACHED. THE REPORTED PROBLEM OF JAWS FAILURE TO CLOSE WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, THE FAILURES OF JACKET KINKED AND LINKS DETACHED COULD BE CAUSED BY OPERATIONAL FACTORS SUCH AS THE TECHNIQUE USED FOR THE DEVICE MANIPULATION. ADDITIONALLY, THE DEVICE PROBABLY COULD HAVE SUFFERED THE DAMAGE DURING INSPECTION IF IT WAS NOT DONE CAREFULLY, OR IF EXCESSIVE FORCE WAS APPLIED WHEN THE SPOOL WAS SLID. THEREFORE, THE INVESTIGATION CONCLUSION CODE OF THIS EVENT IS "ADVERSE EVENT RELATED TO PROCEDURE" SINCE THE ADVERSE EVENTS OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT.
BLOCK E1 INITIAL REPORTER EMAIL HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION OBTAINED ON NOVEMBER 14, 2025. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE. BLOCK H11: THE RETURNED COREDX BIOPSY FORCEPS WAS ANALYZED, AND IT WAS FOUND DURING VISUAL AND MICROSCOPE INSPECTION THAT THE JACKET WAS KINKED, ALSO THE LINKS WERE DETACHED. THE REPORTED PROBLEM OF JAWS FAILURE TO CLOSE WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, THE FAILURES OF JACKET KINKED AND LINKS DETACHED COULD BE CAUSED BY OPERATIONAL FACTORS SUCH AS THE TECHNIQUE USED FOR THE DEVICE MANIPULATION. ADDITIONALLY, THE DEVICE PROBABLY COULD HAVE SUFFERED THE DAMAGE DURING INSPECTION IF IT WAS NOT DONE CAREFULLY, OR IF EXCESSIVE FORCE WAS APPLIED WHEN THE SPOOL WAS SLID. THEREFORE, THE INVESTIGATION CONCLUSION CODE OF THIS EVENT IS "ADVERSE EVENT RELATED TO PROCEDURE" SINCE THE ADVERSE EVENTS OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE JAWS OF THE FORCEPS WAS FOUND STUCK IN AN OPEN POSITION AND UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE JAWS OF THE FORCEPS WAS FOUND STUCK IN AN OPEN POSITION AND UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2025. THE PROCEDURE WAS COMPLETED WITH ANOTHER COREDX FORCEPS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE JAWS OF THE FORCEPS WAS FOUND STUCK IN AN OPEN POSITION AND UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, THE JAWS OF THE FORCEPS WAS FOUND STUCK IN AN OPEN POSITION AND UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303441 | COREDX? | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BOSTON SCIENTIFIC CORPORATION | M00515220 | 0036214718 | 08714729971054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |