HYDRA
Report
- Report Number
- 3005099803-2024-04681
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Date of Event
- September 1, 2024
- Report Date
- January 31, 2025
- Manufacturer
- JIANGSU JIANYU HEALTH MEDICAL CO LTD
- Product Code
- FEQ
- UDI-DI
- 00840253108425
- PMA / PMN Number
- K161482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3 (DATE OF EVENT): APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE. BLOCK H11: HYDRA IRRIGATION TUBING WAS RECEIVED FOR ANALYSIS. A VISUAL INSPECTION OF THE DEVICE SHOWED NO PROBLEMS WITH THE THREADED CAP, OR THE VALVE CONNECTOR. VISUAL INSPECTION OF THE TUBING NOTED THE PRESENCE OF A KNOT HOWEVER, AFTER LOOSENING THE KNOT, NO DAMAGE/PROBLEMS WERE NOTED TO THE TUBING. VISUAL INSPECTION OF THE SOFT TUBING NOTED NO PROBLEMS OR DAMAGE. THE REPORTED COMPLAINT EVENT WAS NOT CONFIRMED. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU)/PRODUCT LABEL. THROUGHOUT ALL TESTING, THE DEVICE BEHAVED NORMALLY, AND VISUAL INSPECTION RESULTS DID NOT INDICATE ANY DAMAGE/DEFECT THAT WOULD LEAD TO FLUID BACKFLOW THROUGH THE IRRIGATION TUBING. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS NO PROBLEM DETECTED, WHICH INDICATES THAT THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED.
BLOCK B3 (DATE OF EVENT): APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN A CHOLANGIOSCOPY PROCEDURE PERFORMED IN COMMON BILE DUCT. DURING THE PROCEDURE, THE VALVE THAT WAS NOT WORKING. THE FLUSHING FLUID RAN BACK INTO THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN A CHOLANGIOSCOPY PROCEDURE PERFORMED IN COMMON BILE DUCT. DURING THE PROCEDURE, THE VALVE THAT WAS NOT WORKING. THE FLUSHING FLUID RAN BACK INTO THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1038627 | HYDRA | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | JIANGSU JIANYU HEALTH MEDICAL CO LTD | SIT-575-15 | 0000230708 | 00840253108425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |