MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SIT-575-15
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: HYDRA
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LT; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20334804
• Report Number: 3005099803-2024-04681
• Device Sequence Number: 20827943
• Product Code: FEQ
• UDI-Device Identifier: 00840253108425
• UDI-Public: 00840253108425
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Model Number: SIT-575-15
• Device Catalogue Number: SIT-575-15
• Device Lot Number: 0000230708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown