MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-10-08 for SPYGLASS DIRECT VISUALIZATION PROBE M00546030 4603 manufactured by Boston Scientific Corporation.
[926481]
It was reported to boston scientific corp in 2008 that a spyglass direct visualization probe was used during an endoscopic retrograde cholangiopancreatography procedure performed the same day. According to the complainant, while testing the probe during prep, it was discovered that "the probe had no picture, no visualization. " it was further reported that this was the first use of the probe. The physician completed the procedure with another spyglass direct visualization probe. There were no pt complications reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
[8099143]
According to the complainant, the suspect device has been disposed of and is not available for return. A device eval cannot be performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05129 |
| MDR Report Key | 1196896 |
| Report Source | 05,07 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-09-09 |
| Date of Event | 2008-09-09 |
| Date Mfgr Received | 2008-09-09 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-02-18 |
| 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 | MYRIAD FIBER IMAGING TECH., INC. |
| Manufacturer Street | 56 SOUTHBRIDGE RD |
| Manufacturer City | DUDLEY MA 01571 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01571 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS DIRECT VISUALIZATION PROBE |
| Product Code | ODF |
| Date Received | 2008-10-08 |
| Model Number | M00546030 |
| Catalog Number | 4603 |
| Lot Number | 0000812801 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-08 |