MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-05 for MICROVASIVE RADIAL JAW 3 SERRATED, W/NEEDL DIAMETER 2.2 CHANNEL 2.8 manufactured by Boston Scientific Corp Microvasive.
[83108]
Difficulty passing biopsy forcep down scope upon second attempt. 1st specimen collected without difficulty. Non-disposable forcep then used without difficulty. Microvasive disposable forcep initially used. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014690 |
| MDR Report Key | 190656 |
| Date Received | 1998-10-05 |
| Date of Report | 1998-09-28 |
| Date of Event | 1998-04-21 |
| Date Added to Maude | 1998-10-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROVASIVE |
| Generic Name | RADIAL JAW |
| Product Code | BWH |
| Date Received | 1998-10-05 |
| Model Number | RADIAL JAW 3 SERRATED, W/NEEDL |
| Catalog Number | DIAMETER 2.2 CHANNEL 2.8 |
| Lot Number | 8010025A |
| ID Number | WORKING LENGTH 240CM |
| Device Expiration Date | 2001-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 185263 |
| Manufacturer | BOSTON SCIENTIFIC CORP MICROVASIVE |
| Manufacturer Address | 480 PLEASANT ST. WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-05 |