MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-20 for RADIAL JAW * M00515030 manufactured by Boston Scientific Corporation.
[5599569]
An elderly female underwent a colonoscopy which was indicated for history of colonic polyps. During the procedure, the biopsy forceps would not cauterize. The cautery unit was checked and reconnected without being able to cauterize. New biopsy forceps device was utilized and the physician was able to successfully use the biopsy forceps without difficulty. ======================manufacturer response for biopsy forceps, radial jaw 4 (per site reporter). ======================call made to boston scientific to customer complaint department. Product will be returned for manufacturer investigation according to manufacturer instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4643581 |
| MDR Report Key | 4643581 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-03-20 |
| Date of Event | 2015-01-27 |
| Report Date | 2015-03-20 |
| Date Reported to FDA | 2015-03-20 |
| Date Reported to Mfgr | 2015-03-31 |
| Date Added to Maude | 2015-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIAL JAW |
| Generic Name | FORCEPS, BIOPSY, ELECTRIC |
| Product Code | BWH |
| Date Received | 2015-03-20 |
| Model Number | * |
| Catalog Number | M00515030 |
| Lot Number | 17354514 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |