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

Model Number SIT-355-15

Device Problem Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

Patient¿s exact age is unknown; however, it was reported that the patient was over the age of 18.The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Mfg site name - endochoice.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a hydra irrigation tubing was used during a colonoscopy procedure performed on (b)(6) 2017.According to the complainant, after a colonoscopy procedure, a yellow fluid was noted in the irrigation tubing in between the sterile water bottle and the scope.The backflow had not reached the sterile water bottle and was not noticed in the tubing between any other cases.Another hydra irrigation tubing was opened and used for the succeeding procedures.There were no patient complications at the conclusion of this procedure and the patient condition was noted to be ¿no injury.¿.

• 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: 7442734
• MDR Text Key: 106027629
• Report Number: 3005099803-2018-01250
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIT-355-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• 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