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

Model Number	SIT-361-100
Medical Device Problem Codes	Leak/Splash (1354); Reflux within Device (1522); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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".
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22586342
• Report Number: 3005099803-2025-03595
• Device Sequence Number: 14587754
• Product Code: FEQ
• UDI-Device Identifier: 00816849016955
• UDI-Public: (01)00816849016955(17)271114(10)241115
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 10/22/2025

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 Model Number: SIT-361-100
• Device Catalogue Number: SIT-361-100
• Device Lot Number: 0000241115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 10/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/21/2025; 10/22/2025
• Date Device Manufactured: 11/15/2024
• 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