MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-23 for OLYMPUS ENDOSCOPIC FLUSHING PUMP OFP UNK manufactured by Keymed (medical & Industrial Equipment), Ltd..
[19620754]
Olympus field svc engineers visited the user facility and inspected the subject device of this report, verified that it operated appropriately, and did not note any anomalies with the device. The device was also noted to be connected correctly to other equipment in the video tower. Olympus followed-up with the user facility via phone and in writing to obtain add'l info regarding this report, however, only limited info was provided regarding the circumstances of the event. The user facility has not yet returned the device for evaluation, but was said to be considering doing so. Olympus continues to investigate this report. If significant add'l info becomes available, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution. This report is one of four related to the same event. See also 8010047-2011-00055, 8010047-2011-00056.
Patient Sequence No: 1, Text Type: N, H10
[19663861]
Olympus was informed that approx three hours after an ercp procedure, the pt expired due to an air embolism. The user facility indicated that they did not believe that the devices or the procedure performed caused the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2011-00002 |
| MDR Report Key | 2039374 |
| Report Source | 06 |
| Date Received | 2011-03-23 |
| Date of Report | 2011-02-22 |
| Date of Event | 2011-02-18 |
| Date Mfgr Received | 2011-02-22 |
| Date Added to Maude | 2011-04-06 |
| 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 AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Street | STOCK RD. |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SS25QH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSCOPIC FLUSHING PUMP |
| Generic Name | FLUSHING PUMP |
| Product Code | FEQ |
| Date Received | 2011-03-23 |
| Model Number | OFP |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Address | STOCK RD. SOUTHEND-ON-SEA, ESSEX SS25QH UK SS25QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-23 |