MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-07 for BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE manufactured by Boston Scientific.
[46862248]
During procedure (egd with mac anesthesia), esophageal specimens were being obtained. After obtaining a few specimens, doctor noted/stated the needle of the biopsy forceps was bent and requested another forceps. Old forceps was set aside and further biopsies obtained with new forceps per doctor without problem. Procedure was completed without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062736 |
| MDR Report Key | 5707093 |
| Date Received | 2016-06-07 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-05-24 |
| Date Added to Maude | 2016-06-08 |
| 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 | 3 |
| 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 | 0 |
| Brand Name | BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE |
| Generic Name | RADIAL JAW |
| Product Code | FFF |
| Date Received | 2016-06-07 |
| Lot Number | 19148700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-07 |