MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-24 for OLYMPUS VIDEO TELESCOPE A50021A manufactured by Olympus Winter & Ibe Gmbh.
[2750550]
The user facility reported that during a therapeutic laparoscopic cholecystectomy procedure, the users experienced a complete loss of image. The procedure was completed using a different device. There was no pt injury report.
Patient Sequence No: 1, Text Type: D, B5
[9833914]
The device referenced in this report was returned to olympus for eval. The eval was able to duplicate the user's report of image difficulty. The image flickered, distorted and then the image was lost when the video cable was manipulated. The eval revealed that the outer tube (r-unit) of the telescope was bent, dented at the distal end and there were minor scratches on the objective lens. The cable had a damaged signal wire at the r-unit connection section. The cause of the image difficulty was likely due to physical damage to the cable unit and outer tube, which is related user handling. The device was serviced and returned to the user facility. This report is being submitted as a medical device report in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2012-00019 |
| MDR Report Key | 2556642 |
| Report Source | 06 |
| Date Received | 2012-04-24 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-26 |
| Date Added to Maude | 2012-09-13 |
| 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 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 | 2012-04-24 |
| Returned To Mfg | 2012-03-26 |
| 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 | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-24 |