HEDGEHOG SBB-382-50 60252

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-02 for HEDGEHOG SBB-382-50 60252 manufactured by Boston Scientific Corporation.

Event Text Entries

[140635973] 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.
Patient Sequence No: 1, Text Type: N, H10


[140635974] It was reported to boston scientific corporation that a hedgehog double bundle brush was used during washing of the scope on (b)(6) 2019. According to the complainant, during washing of the endoscope, it was noted that bristles from the brush detached. Another brush was used to complete the cleaning of the scope. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-01600
MDR Report Key8473937
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-02
Date of Report2019-05-13
Date of Event2019-03-07
Date Mfgr Received2019-04-18
Device Manufacturer Date2018-04-14
Date Added to Maude2019-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY ,
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD
Manufacturer StreetNO 699 PINAN ROAD PUZHAUNG LINHU TOWN,
Manufacturer CityWUZHONG DISTRICT, SUZHOU 21505
Manufacturer CountryCH
Manufacturer Postal Code21505
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEDGEHOG
Generic NameACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
Product CodeMNL
Date Received2019-04-02
Returned To Mfg2019-04-01
Model NumberSBB-382-50
Catalog Number60252
Lot Number0000180409
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-02

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