HYDRA
Report
- Report Number
- 3005099803-2024-04680
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Date of Event
- September 1, 2024
- Report Date
- January 29, 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: 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: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. THE RETURNED DEVICE WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED HYDRA IRRIGATION TUBING WAS ANALYZED. VISUAL INSPECTION OF THE DEVICE SHOWED NO PROBLEMS WITH THE BOTTLE WEIGHT, THREADED CAP, OR THE LUER CONNECTOR. VISUAL INSPECTION OF THE SOFT TUBING NOTED NO PROBLEM OR DAMAGE. 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: 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 ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE ONE-WAY CHECK VALVE DID NOT FUNCTION PROPERLY. 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 ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE ONE-WAY CHECK VALVE DID NOT FUNCTION PROPERLY. 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 |
|---|---|---|---|---|---|---|---|
| 1488933 | 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 |