MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-18 for OLYMPUS IRRIGATION TUBING FOR FLUSHING PUMP OFP 7501669 manufactured by Keymed Ltd..
[21761027]
Olympus was informed that the irrigation tubing was leaking and a nurse had slipped and fallen due to the leak.
Patient Sequence No: 1, Text Type: D, B5
[21855619]
Olympus followed up with the user facility to obtain add'l info regarding the report, and was informed that the nurse did not sustain injury as a result of the reported incident. The nurse reportedly had two knee replacement prior to the reported incident and the nurse reportedly applied cold pack on her knees after the incident, but did not require medical treatment. The nurse is reportedly doing well. The user facility personnel discarded the subject device following receipt of the letter from olympus, as olympus has initiated a corrective action to address complaints associated with water leaking from the irrigation tubing used with the olympus flushing pump. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2012-00002 |
| MDR Report Key | 2436204 |
| Report Source | 06 |
| Date Received | 2012-01-18 |
| Date of Report | 2011-12-21 |
| Date Mfgr Received | 2011-12-21 |
| Date Added to Maude | 2012-08-08 |
| 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 |
| 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 | KEYMED LTD. |
| Manufacturer Street | STOCK ROAD KEYMED HOUSE |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS25QH |
| 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 IRRIGATION TUBING FOR FLUSHING PUMP |
| Generic Name | IRRIGATION TUBING FOR OFP |
| Product Code | FEQ |
| Date Received | 2012-01-18 |
| Model Number | OFP |
| Catalog Number | 7501669 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED LTD. |
| Manufacturer Address | STOCK ROAD KEYMED HOUSE SOUTHEND-ON-SEA, ESSEX SS25QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-18 |