MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for OLYMPUS OLYMPUS ENF-V3 manufactured by Olympus Medical Systems Corp..
[182546431]
Scope # (b)(4) was used with no signs of damage. It was sent out and then returned two days later with a label that stated "scope failed the leak test". We have all witnessed different carrier's handling the scopes in a very careless manner. The scopes leave clinic in good condition and return damaged. Too many scopes have failed a leak test this year (6? ). This is a concern regarding both the care, transportation, and possible sterile processing of equipment. We recently had another scope, that was not used, not had not failed a leak test, go out to be cleaned and failed the leak test. Also, based upon this, the scope was sent in the afternoon but didn't get processed by spd until more than 24 hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9805348 |
| MDR Report Key | 9805348 |
| Date Received | 2020-03-09 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-10 |
| Report Date | 2019-12-20 |
| Date Reported to FDA | 2019-12-20 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| 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 | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
| Product Code | EOB |
| Date Received | 2020-03-09 |
| Model Number | OLYMPUS ENF-V3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |