MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for OLYMPUS MAJ-1632 manufactured by Olympus Surgical Technologies America.
[141920553]
From staff: patient had documented bonded front tooth prior to procedure on the anesthesia record. When patient woke from procedure she informed recovery nurse that her tooth was broken. Certified registered nurse anesthetist and procedure doctor were informed and came to post op and examined and spoke to patient. Charge nurse and department head were aware. Patient stated that her tooth had been repaired several years ago. Patient had a bite block inserted before the esophagogastroduodenoscopy, the scope inserted through the bite block and the bite block taken out after the procedure. Patient taken to post op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8513569 |
| MDR Report Key | 8513569 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-12 |
| Report Date | 2019-04-04 |
| Date Reported to FDA | 2019-04-04 |
| Date Reported to Mfgr | 2019-04-15 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OLYMPUS |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-04-15 |
| Model Number | MAJ-1632 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| Manufacturer Address | 2400 RINGWOOD AVE. SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-15 |