MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-12-14 for MICROKNIFE * 3281 manufactured by Boston Scientific.
[407976]
A microknife was used for therapeutic purposes. During the procedue, the needle broke off inside of the pt's duodenum. The procedure was completed with another device. There were no complications or intervention reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-2005-00195 |
| MDR Report Key | 653978 |
| Report Source | 05,06 |
| Date Received | 2005-12-14 |
| Date of Report | 2005-08-11 |
| Date of Event | 2005-08-11 |
| Date Mfgr Received | 2005-08-11 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2005-12-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 780 BROOKSIDE DR |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROKNIFE |
| Generic Name | SECURING |
| Product Code | EMF |
| Date Received | 2005-12-14 |
| Model Number | * |
| Catalog Number | 3281 |
| Lot Number | 7675612 |
| ID Number | * |
| Device Expiration Date | 2007-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 643447 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Baseline Brand Name | ENDOSCOPIC ELECTROSURGICAL UNIT & ACCESS. |
| Baseline Generic Name | MICROKNIFE XL |
| Baseline Model No | NA |
| Baseline Catalog No | 3281 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-14 |