MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-10 for OLYMPUS FLUSHING PUMP OFP manufactured by Southend-on-sea.
[19939337]
The device referenced in this report was not returned to olympus for evaluation. An olympus endoscope support specialist and sales representative have visited the user facility and provided in-service trainings to hospital personnel on proper reprocessing practices. This report is being submitted as a medical device report in an abundance of caution. Reference mfr number: 8010047-2009-00067 for the other related report associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[20024482]
Olympus was informed that the user facility had not properly reprocessed the ofp flushing pump water bottle since its initial introduction and installation in may 2004. The user facility is currently notifying (b)(6) patients that received procedures during this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2009-00001 |
| MDR Report Key | 1360349 |
| Report Source | 05,06 |
| Date Received | 2009-04-10 |
| Date of Report | 2009-03-12 |
| Date Mfgr Received | 2009-03-12 |
| Date Added to Maude | 2010-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | SOUTHEND-ON-SEA |
| Manufacturer City | ESSEX SS2-5QH |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SS2-5QH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS FLUSHING PUMP |
| Generic Name | FLUSHING PUMP |
| Product Code | FEQ |
| Date Received | 2009-04-10 |
| Model Number | OFP |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHEND-ON-SEA |
| Manufacturer Address | ESSEX SS2-5QH UK SS2-5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-04-10 |