SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-05-17 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[18058652] It was reported to boston scientific corporation that a spyscope access and delivery catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2013. According to the complainant, during preparation for the procedure a hole was noted in the spyscope's inner packaging rendering it unsterile. The procedure was completed with another spyscope with no patient complications. The patient's condition has been describes as fine.
Patient Sequence No: 1, Text Type: D, B5


[18323614] According to the complainant, the device was disposed of and is not available for evaluation. At this time, we are unable to determine the relationship between the device and the cause for this event. If there is any further relevant information received, a supplemental medwatch report will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2013-03981
MDR Report Key3118234
Report Source05,07
Date Received2013-05-17
Date of Report2013-04-25
Date of Event2013-04-25
Date Mfgr Received2013-04-25
Device Manufacturer Date2012-12-28
Date Added to Maude2013-05-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactEMP. INGRID MATTE
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1MEDVENTURE TECHNOLOGY CORPORATION
Manufacturer Street2301 CENTENNIAL BOULEVARD
Manufacturer CityJEFFERSONVILLE IN 47130
Manufacturer CountryUS
Manufacturer Postal Code47130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPYGLASS DIRECT VISUALIZATION SYSTEM
Generic NameMINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY
Product CodeODF
Date Received2013-05-17
Model NumberM00546230
Catalog Number4623
Lot NumberML00001185
Device Expiration Date2013-12-31
OperatorNURSE
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-17

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