MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ED-530XT manufactured by Fujifilm Medical Systems U.s.a., Inc.
[182191373]
Upon removal of ercp scope, it was noticed that tip of ercp scope was missing. Missing piece was found in patient's mouth and removed successfully.
Patient Sequence No: 1, Text Type: D, B5
[187395994]
Upon removal of ercp scope, it was noticed that tip of ercp scope was missing. Missing piece was found in patient's mouth and removed successfully. Patient was under anesthesia and tip was missing when scope was removed. Missing piece was found in patient's mouth by finger sweep prior to extubation. No harm to patient. No further treatment needed. The device was sent back to the company. I have not received any information regarding the scope. I do not have the age of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9792669 |
| MDR Report Key | 9792669 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-03 |
| Report Date | 2020-01-08 |
| Date Reported to FDA | 2020-01-08 |
| Date Reported to Mfgr | 2020-03-05 |
| Date Added to Maude | 2020-03-05 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | EOQ |
| Date Received | 2020-03-05 |
| Model Number | ED-530XT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM MEDICAL SYSTEMS U.S.A., INC |
| Manufacturer Address | 81 HARTWELL AVE, SUITE 300 LEXINGTON MA 02421 US 02421 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |