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 |