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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 11/12/2019
Type of Reportable Event Malfunction
Additional 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 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 or Problem Description
It was reported to boston scientific corporation that a hedgehog brush was used during scope cleaning on (b)(6) 2019.According to the complainant, during scope cleaning, the bristles of the brush detached and got stuck in to the scope valves.The bristles were reported to have been removed manually.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 Key9437900
Report Number3005099803-2019-05872
Device Sequence Number2696850
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) 12/09/2019
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
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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