MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for ENF-VH manufactured by Olympus Corporation Of The Americas.
[74499872]
Patient Sequence No: 1, Text Type: N, H10
[74499873]
The ent video scope keeps failing the leak test at the connection point. We can see air bubbles around the joint of the connection. This has been a repeating issue for the past year and the vendor has come to our facility to conduct an evaluation and states that we and the operator are doing nothing wrong. But we continue to have failures and the repairs are very expensive each time (even though the problem is not with operation of the scope or how we perform the leak test). I have pictures of the break and the failed leak test. Manufacturer response for ent video scope, enf-vh (per site reporter): they came to our site to evaluate the procedure and cleaning. They state that because they are watching we are doing everything right, but once the vendor leaves the operators go back to their old routine and mishandle the scope and cause the leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6545912 |
| MDR Report Key | 6545912 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-04-07 |
| Report Date | 2017-04-12 |
| Date Reported to FDA | 2017-04-12 |
| Date Reported to Mfgr | 2017-04-12 |
| Date Added to Maude | 2017-05-04 |
| 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 |
| 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 | ENF-VH |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-04-10 |
| Model Number | ENF-VH |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS |
| Manufacturer Address | 2400 RINGWOOD AVE. SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |