MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-05 for OLYMPUS VIDEO TELESCOPE A50021A manufactured by Olympus Winter & Ibe Gmbh.
[2882594]
The user facility reported that during a laparoscopic appendectomy, the user experienced a total loss of image. The procedure was completed with a different, but similar device. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10180803]
The device referenced in this report was returned to olympus for eval. The eval was able to duplicate the user's report of image loss. The image was completely black with some flickering. The eval noted minor debris underneath the light guide cover glass. The outer tube was critically bent and the device did not pass the light transmission testing. There were dents and scratches on the video connector. The image difficulty was attributed to a damaged video cable. The device was serviced and returned to the user facility. The report is being submitted as a medical device report in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00101 |
| MDR Report Key | 2748126 |
| Report Source | 06 |
| Date Received | 2012-09-05 |
| Date of Report | 2012-08-13 |
| Date of Event | 2012-08-11 |
| Date Mfgr Received | 2012-08-13 |
| Date Added to Maude | 2012-10-15 |
| 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 STORM-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 | KUEHNSTRABE 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 | 2012-09-05 |
| Returned To Mfg | 2012-08-14 |
| Model Number | A50021A |
| Catalog Number | A50021A |
| 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 | KUEHNSTRABE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-05 |