MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-18 for OLYMPUS VIDEO TELESCOPES A50021A manufactured by Olympus Winter & Ibe Gmbh.
[1650827]
The user facility reported that during a therapeutic lap-appendectomy procedure, the users experienced a complete loss of image. The procedure was completed using a different, but similar device. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[8800999]
Olympus followed up on this report and was informed that the users had reportedly experienced intermittent image issues in the days prior to the event, and had elected to use the device. The user facility returned the device to olympus for eval. The eval confirmed the user's claim of a complete image loss. The eval found that the outer tube was bent and dented, and the contact pins on the video connector were damaged and appeared burnt. Corrosion was present around the switch unit. In addition, the light guide tube could not be removed and there were loose light guide posts, and dents on the light guide cable. The device was serviced and returned to the user facility. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2010-00042 |
| MDR Report Key | 1911493 |
| Report Source | 05,06 |
| Date Received | 2010-11-18 |
| Date of Report | 2010-11-02 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2010-10-26 |
| Date Added to Maude | 2012-01-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS VIDEO TELESCOPES |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2010-11-18 |
| Returned To Mfg | 2010-11-02 |
| Model Number | A50021A |
| 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 WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-18 |