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 2012-03-09 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[2552729] It was reported to boston scientific corporation that a spyscope access & delivery catheter was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure. According to the complainant, the spyscope was used to complete the procedure. However, following the ercp, "a tubular piece of plastic or rubber," approximately 2mm x 7mm in size and "white/yellow" in appearance, was recovered from the patient's common bile duct. The physician suspects that the fragment may have originated from the spyscope; however, subsequent examination of the device identified no damage. Reportedly, no malfunction of the spyscope occurred. No patient complications resulted from this event. The patient's condition at the conclusion of the procedure was reported as being fine. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


[9672318] Concomitant medical device: olympus scope. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the device was not used past its expiry date. The complainant indicated that the device 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2012-00967
MDR Report Key2485072
Report Source05,07
Date Received2012-03-09
Date of Report2012-02-10
Date Mfgr Received2012-02-10
Date Added to Maude2012-03-09
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. CHARLES MONTGOMERY
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 Received2012-03-09
Model NumberM00546230
Catalog Number4623
OperatorPHYSICIAN
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
101. Required No Informationntervention 2012-03-09

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