MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2008-10-01 for SPYGLASS IRRIGATION PUMP M00546140 4614 manufactured by Boston Scientific Corporation.
[20823936]
Although the complainant has indicated that the suspect device is being returned for eval, it has not been received. The device eval has not been performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[20836777]
It was reported to boston scientific corp in 2008 that a spyglass irrigation pump was planned to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to be performed the same day. According to the complainant, during preparation, the pump failed to continuously rotate its rollers to sufficiently irrigate through the spyglass system. Another device (unk mfr) was used to complete the procedure. 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 "stable. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2008-04977 |
| MDR Report Key | 1196571 |
| Report Source | 00,01,05,07 |
| Date Received | 2008-10-01 |
| Date of Report | 2008-09-02 |
| Date of Event | 2008-09-02 |
| Date Mfgr Received | 2008-09-02 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2009-02-19 |
| 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 | MEDICAL SCIENTIFIC, INC. |
| Manufacturer Street | 125 JOHN HANCOCK RD |
| Manufacturer City | TAUNTON MA 02780 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYGLASS IRRIGATION PUMP |
| Product Code | FEQ |
| Date Received | 2008-10-01 |
| Model Number | M00546140 |
| Catalog Number | 4614 |
| Lot Number | 0000001080 |
| 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 | 2008-10-01 |