MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number SIT-361-100

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #: 3005099803-2018-01611 for the other associated device information.It was reported to boston scientific corporation that a hydra irrigation tubing was used in conjunction with a hydra olympus water jet connector during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, after one procedure, a backflow into the tubing was noted during clean up.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: HYDRA
• Type of Device: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7542470
• MDR Text Key: 109192556
• Report Number: 3005099803-2018-01610
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIT-361-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1