MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-05 for OLYMPUS VIDEO TELESCOPES WA50011A NA manufactured by Olympus Winter & Ibe Gmbh.
[17960519]
Olympus contacted the user facility to obtain additional info regarding this report. The user facility reported that the complete loss of image was experienced toward the beginning of the procedure. The device referenced in this report was returned to olympus for eval. The eval confirmed image difficulties. Following a brief period of operation, image on the scope became intermittent, alternating between a white and flickering image. The image was also distorted. Cracks were noted on the video connector below the screws on both sides. Button #3 was missing and there were minor bends, dents, and scratches noted on the outer tube. The device is pending instructions from the user facility regarding service. This report is being submitted as a medical device report in an abundance of caution. This medial device report is being re-submitted with a revised mfr # to correct the previous submission. The report had initially been inadvertently submitted as 9610773-2010-00001, and is being revised to 9610773-2011-00001.
Patient Sequence No: 1, Text Type: N, H10
[17971372]
Olympus was informed that during a therapeutic laparoscopic hysterectomy procedure, the users experienced a complete less of image. The procedure was completed with a different olympus telescope. There was no report of pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2011-00001 |
| MDR Report Key | 2280995 |
| Report Source | 06 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-01-05 |
| Date of Event | 2010-11-23 |
| Date Mfgr Received | 2011-01-05 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965668 |
| 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 | TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-10-05 |
| Returned To Mfg | 2010-12-03 |
| Model Number | WA50011A |
| Catalog Number | NA |
| 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 | 2011-10-05 |