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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
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BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE Back to Search Results
Model Number SBB-382-50
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is a non-sterile device with no expiration date.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a hedgehog double bundle brush was used during scope cleaning on (b)(6) 2019.According to the complainant, while cleaning the scope, bristles detached from the brush head and got caught in the spring part of the aspiration button.It was not reported how the detached bristles were removed.There was no patient involvement.
 
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Brand Name
HEDGEHOG
Common Device Name
ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8631821
Report Number3005099803-2019-02603
Device Sequence Number2354461
Product Code MNL
UDI-Device Identifier00816849016900
UDI-Public00816849016900
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 05/22/2019
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 NumberSBB-382-50
Device Catalogue Number60252
Device Lot Number0000180726
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2019
Initial Report FDA Received Date05/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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