MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-04-08 for MICROKNIFE * 3281 manufactured by Boston Scientific.
[410806]
A needle knife was used for the therapeutic purposes. During the procedure, the needle would not extend from the tip. The procedure was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-2005-00041 |
| MDR Report Key | 589693 |
| Report Source | 05,06 |
| Date Received | 2005-04-08 |
| Date of Report | 2005-01-28 |
| Date of Event | 2005-01-20 |
| Date Mfgr Received | 2005-03-10 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-04-12 |
| 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 017601537 |
| Manufacturer Country | US |
| Manufacturer Postal | 017601537 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORP |
| 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 | NEEDLEKNIFE |
| Product Code | EMF |
| Date Received | 2005-04-08 |
| Returned To Mfg | 2005-03-10 |
| Model Number | * |
| Catalog Number | 3281 |
| Lot Number | 6235083 |
| ID Number | * |
| Device Expiration Date | 2006-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 579542 |
| 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 | 2005-04-08 |