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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 12/16/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Expiration date.This is a non-sterile device with no expiration date.(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 or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during scope cleaning on (b)(6) 2020.According to the complainant, during the scope cleaning, the bristles were stuck on the button.The technician removed the bristles from the button by hand.Scope cleaning was completed using another hedgehog brush.There was no patient involvement with this event.
 
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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 Key11166022
Report Number3005099803-2020-06670
Device Sequence Number13664616
Product Code MNL
UDI-Device Identifier00816849016900
UDI-Public00816849016900
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/13/2021
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 Number0000190302
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/16/2020
Initial Report FDA Received Date01/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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