MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for BOSTON SCIENTIFIC, RADIAL JAW 4 M00515180 manufactured by Boston Scientific.
[42614071]
While performing forceps biopsy a noise was heard, instrument removed and inspected, revealing broken biting mechanism. Wires holding jaws together (normal on bottom) broke, allowing the jaws to pivot (top forceps), increasing the size approximately 3-4x and exposing sharp edges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5573049 |
| MDR Report Key | 5573049 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-02 |
| Date Facility Aware | 2016-03-02 |
| Report Date | 2016-03-29 |
| Date Reported to FDA | 2016-04-01 |
| Date Reported to Mfgr | 2016-04-01 |
| Date Added to Maude | 2016-04-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC, RADIAL JAW 4 |
| Generic Name | BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2016-04-11 |
| Returned To Mfg | 2016-03-15 |
| Model Number | RADIAL JAW 4 |
| Catalog Number | M00515180 |
| Lot Number | 18546277 |
| Device Expiration Date | 2018-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MALBOROUGH MA 017521234 US 017521234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-04-11 |