SPYBITE BIOPSY FORCEPS M00546270 4627

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 2008-10-24 for SPYBITE BIOPSY FORCEPS M00546270 4627 manufactured by Boston Scientific Corporation.

Event Text Entries

[960143] Note: this report pertains to the third of five devices reported for the event. It was reported to boston scientific corporation on september 24, 2008, that a distal bile duct perforation was observed after a procedure performed on the previous month, using a spybite biopsy forceps device (patient age, gender and weight are unknown). The patient was admitted to the hospital and later released; the patient's conditions was reported to be "fine". According to the complainant, the relationship between the duct perforation and the spybite forceps device is unknown. Refer to mfr reports #3005099803-2008-05487, 3005099803-2008-05491, 3005099803-2008-05492, and 3005099803-2008-05502 for the other four devices used in the procedure.
Patient Sequence No: 1, Text Type: D, B5


[8213213] The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. According to the complainant, the suspect device has been disposed and is not available for return. A device evaluation cannot be performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-05490
MDR Report Key1211097
Report Source05,07
Date Received2008-10-24
Date of Report2008-09-24
Date of Event2008-08-26
Date Mfgr Received2008-09-24
Date Added to Maude2008-10-30
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 ContactKEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836264
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street8600 N.W. 41ST STREET
Manufacturer CityMIAMI FL 33166
Manufacturer CountryUS
Manufacturer Postal Code33166
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPYBITE BIOPSY FORCEPS
Product CodeODF
Date Received2008-10-24
Model NumberM00546270
Catalog Number4627
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1261025
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMIAMI FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2008-10-24

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