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.
[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
Report Number | 3005099803-2008-05490 |
MDR Report Key | 1211097 |
Report Source | 05,07 |
Date Received | 2008-10-24 |
Date of Report | 2008-09-24 |
Date of Event | 2008-08-26 |
Date Mfgr Received | 2008-09-24 |
Date Added to Maude | 2008-10-30 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | KEN HIRAKAWA |
Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
Manufacturer City | MARLBOROUGH MA 01752 |
Manufacturer Country | US |
Manufacturer Postal | 01752 |
Manufacturer Phone | 5086836264 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | 8600 N.W. 41ST STREET |
Manufacturer City | MIAMI FL 33166 |
Manufacturer Country | US |
Manufacturer Postal Code | 33166 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SPYBITE BIOPSY FORCEPS |
Product Code | ODF |
Date Received | 2008-10-24 |
Model Number | M00546270 |
Catalog Number | 4627 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 1261025 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | MIAMI FL US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Other | 2008-10-24 |