MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-27 for OLYMPUS TJF-160VF manufactured by Olympus Medical Systems Corporation.
[899712]
The user facility reported that during a therapeutic endoscopic retrograde cholangiopancreatography, the forceps elevator became non-functional as a non-functional as a non-olympus stent was being implanted in the patient's bile duct. The user facility reportedly successfully reimplanted the same stent utilizing a different, but similar device. There was no patient injury and no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
[8071373]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of the forceps elevator not functioning due to a broken elevator wire at the forceps raiser. The right/left free release knob was also found loose and engaging when the right/left angulation knob was turned due to a damaged locking mechanism. The cause of the user's experience was attributed to excessive stress. This report is being filed as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00108 |
| MDR Report Key | 1067178 |
| Report Source | 05,06 |
| Date Received | 2008-06-27 |
| Date of Report | 2008-06-04 |
| Date Added to Maude | 2009-06-18 |
| 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 AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORP |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | EVIS EXERA DUODENOVIDEOSCOPE |
| Product Code | FAK |
| Date Received | 2008-06-27 |
| Model Number | TJF-160VF |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-27 |