HYDRA
Report
- Report Number
- 3005099803-2025-03595
- Event Type
- Malfunction
- Date Received
- July 24, 2025
- Date of Event
- June 26, 2025
- Report Date
- October 22, 2025
- Manufacturer
- JIANGSU JIANYU HEALTH MEDICAL CO LTD
- Product Code
- FEQ
- UDI-DI
- 00816849016955
- PMA / PMN Number
- K161482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF TUBING LEAK/SPLASH. IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF TUBING REFLUX WITHIN DEVICE.
ADDITIONAL INFORMATION: B5 (DESCRIBE EVENT OR PROBLEM) AND BLOCK H6 (IMDRF DEVICE CODES) BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF TUBING LEAK/SPLASH. IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF TUBING REFLUX WITHIN DEVICE.
ADDITIONAL INFORMATION: B5 (DESCRIBE EVENT OR PROBLEM) AND BLOCK H6 (IMDRF DEVICE CODES) BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF TUBING LEAK/SPLASH. IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF TUBING REFLUX WITHIN DEVICE. BLOCK H11: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED TO IDENTIFY ANY DEFECT WITH THE DEVICE. WITHOUT A PRODUCT RETURNED, NO PRODUCT ANALYSIS COULD BE CONDUCTED. A MEDIA INSPECTION WAS PERFORMED TO THE PHOTOS AND VIDEO PROVIDED BY THE CUSTOMER. ALTHOUGH THE MEDIA DOES NOT PROVIDE ENOUGH EVIDENCE TO CONFIRM THE REPORTED EVENT OF TUBING LEAK, REFLUX WITHIN DEVICE AND USE OF DEVICE ISSUE - USER ERROR; THE PHOTO SHOWS CONTAMINATED LIQUID INSIDE THE TUBING POTENTIALLY CAUSED BY THE LEAK. WITH ALL THE AVAILABLE INFORMATION BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS CONFIRMED. BASED ON ALL GATHER INFORMATION, IT IS POSSIBLE TO CONCLUDE THAT THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT WAS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. ACCORDING TO THE HYDRA WJC DFU, THE USE OF THIS DEVICE WITH ANY OTHER IRRIGATION TUBING COULD POTENTIALLY IMPACT PERFORMANCE, INCLUDING THE REPORTED EVENT OF LEAK. THEREFORE, THE EVENT IS ASSIGNED A PROBABLE CAUSE OF FAILURE TO FOLLOW INSTRUCTIONS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA OLYMPUS WATER JET CONNECTOR WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF ESOPHAGEAL VARICES ON (B)(6) 2025. DURING THE PROCEDURE WHILE LIGATING THE ESOPHAGEAL VARICES, A LEAK WAS NOTICED ACROSS THE ENDOSCOPE LENS WHILE APPLYING SUCTION. AT THE END OF THE PROCEDURE, IT WAS FOUND OUT THAT THE CONTAMINATED FLUID HAD RUN THROUGH THE HYDRA OLYMPUS WATER JET CONNECTOR AND ENTERED THE JET WASHER TUBING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED".
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA OLYMPUS WATER JET CONNECTOR (WJC) WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF ESOPHAGEAL VARICES ON (B)(6) 2025. DURING THE PROCEDURE WHILE LIGATING THE ESOPHAGEAL VARICES, A LEAK WAS NOTICED ACROSS THE ENDOSCOPE LENS WHILE APPLYING SUCTION. AT THE END OF THE PROCEDURE, IT WAS FOUND OUT THAT THE CONTAMINATED FLUID HAD RUN THROUGH THE HYDRA OLYMPUS WATER JET CONNECTOR AND ENTERED THE JET WASHER TUBING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED". ADDITIONAL INFORMATION WAS RECEIVED ON JULY 28, 2025: IT WAS REPORTED THAT THE HYDRA OLYMPUS WATER JET CONNECTOR WAS NOT USED WITH HYDRA IRRIGATION TUBING (IT). THE HYDRA WJC IFU (INSTRUCTIONS FOR USE) INCLUDES THE PRECAUTION: THE HYDRA DISPOSABLE AUXILIARY WJC IS INTENDED FOR USE WITH HYDRA IT ONLY. USE OF THIS DEVICE WITH ANY OTHER IRRIGATION TUBING COULD POTENTIALLY IMPACT PERFORMANCE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA OLYMPUS WATER JET CONNECTOR (WJC) WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF ESOPHAGEAL VARICES ON (B)(6) 2025. DURING THE PROCEDURE WHILE LIGATING THE ESOPHAGEAL VARICES, A LEAK WAS NOTICED ACROSS THE ENDOSCOPE LENS WHILE APPLYING SUCTION. AT THE END OF THE PROCEDURE, IT WAS FOUND OUT THAT THE CONTAMINATED FLUID HAD RUN THROUGH THE HYDRA OLYMPUS WATER JET CONNECTOR AND ENTERED THE JET WASHER TUBING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FULLY RECOVERED". ADDITIONAL INFORMATION WAS RECEIVED ON JULY 28, 2025: IT WAS REPORTED THAT THE HYDRA OLYMPUS WATER JET CONNECTOR WAS NOT USED WITH HYDRA IRRIGATION TUBING (IT). THE HYDRA WJC IFU (INSTRUCTIONS FOR USE) INCLUDES THE PRECAUTION: THE HYDRA DISPOSABLE AUXILIARY WJC IS INTENDED FOR USE WITH HYDRA IT ONLY. USE OF THIS DEVICE WITH ANY OTHER IRRIGATION TUBING COULD POTENTIALLY IMPACT PERFORMANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717813 | HYDRA | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | JIANGSU JIANYU HEALTH MEDICAL CO LTD | SIT-361-100 | 0000241115 | 00816849016955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |