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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
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BOSTON SCIENTIFIC - MARLBOROUGH HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE Back to Search Results
Model Number SIT-355-15
Device Problem Reflux within Device (1522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.(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
It was reported to boston scientific corporation that a hydra irrigation tubing was used in a procedure.According to the complainant, during irrigation, a backflow into the tubing was noted.
 
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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 Key7410682
MDR Text Key105294312
Report Number3005099803-2018-01114
Device Sequence Number1
Product Code FEQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIT-355-15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2018
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 Number1
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