MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-11-17 for OLYMPUS VIDEO TELESCOPES WA50023B UNK manufactured by Olympus Winter & Ibe Gmbh.
[21759987]
Olympus was informed that during a therapeutic laparoscopic cholecystectomy procedure, the image started out darker than usual, and lines began to develop on the image approx 5-10 mins into the procedure, the image was said to have been progressively getting worst which ultimately became invisible. The intended procedure was said to have been completed with a laparoscope. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[21869306]
The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report. The eval found the image flickered with horizontal lines and blackout completely after being burn-in for 10 mins. The outer tube was bent with multiple dents noted around the frame at the distal tip. The reported phenomenon was attributed to the light guide cable unit. 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 | 9610773-2011-00034 |
| MDR Report Key | 2351003 |
| Report Source | 06,07 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-18 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-03-16 |
| 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 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 | 2011-11-17 |
| Returned To Mfg | 2011-10-21 |
| Model Number | WA50023B |
| Catalog Number | UNK |
| Lot Number | NA |
| ID 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 | 2011-11-17 |