MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-06-17 for OLYMPUS VIDEO TELESCOPE A50021A UNK manufactured by Olympus Winter & Ibe Gmbh.
[2114218]
Olympus was informed that during a therapeutic bilateral arthrolectomy procedure, there was a complete loss of image. The procedure was completed with a different but similar device. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[9167061]
Olympus followed-up with the user facility to gather additional info regarding this report. The user facility reported that the subject device was functioning properly during the first half of the procedure, however, when the subject device reached the vasculature and the surgeon was cauterizing vessels, the image became intermittent, and was subsequently lost. The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report. The image was observed to flicker intermittently when the outer tube was tapped. A severe dent was noted on the outer tube which appears to have caused or contributed to the reported event. The cause of the dent was attributed to mishandling. The device has now been refurnished. 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 | 9610773-2011-00015 |
| MDR Report Key | 2140392 |
| Report Source | 06,07 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-05-20 |
| Date Mfgr Received | 2011-05-20 |
| Date Added to Maude | 2011-08-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 TELESCOPE |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-06-17 |
| Returned To Mfg | 2011-05-25 |
| Model Number | A50021A |
| 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 | KEUHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-17 |