MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-29 for OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE PJF-160 manufactured by Olympus Medical System Corporation.
[1433638]
The user facility reported that during an endoscopic retrograde cholangiopancreatography (ercp) procedure the elevator would reportedly not lift when manipulated inside the patient. The procedure was aborted, as there was reportedly no spare device available.
Patient Sequence No: 1, Text Type: D, B5
[8740820]
Olympus followed up with the user facility to obtain more information regarding the report. The user facility reported the patient's colon was not tortuous. One of the users reported that the device was functioning properly outside the patient, but would not function properly once inserted into the patient. There was no adverse impact reported to the patient. The device referenced in this report was returned to olympus for evaluation. The evaluation found that the elevator raiser would not lift, and the elevator water channel was clogged. The device has been refurbished. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00187 |
| MDR Report Key | 1853629 |
| Report Source | 05,06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-08-31 |
| Date of Event | 2010-08-26 |
| Date Mfgr Received | 2010-08-31 |
| Date Added to Maude | 2010-11-18 |
| 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 | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE |
| Generic Name | DUODENOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2010-09-29 |
| Returned To Mfg | 2010-08-31 |
| Model Number | PJF-160 |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |