MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-01 for OLMPUS VIDEO TELESCOPES A50021A manufactured by Olympus Winter & Ibe Gmbh.
[3170337]
Olympus was informed that the image went completely dark during an unidentified procedure. There was no report of any pt harm.
Patient Sequence No: 1, Text Type: D, B5
[10568462]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reported that the reported phenomenon occurred during a laparoscopic procedure where the users were unable to restore the image after it went completely black. The intended procedure was said to have been completed. The device referenced in this report was returned to olympus for evaluation. The evaluation found the image with spotted dark stain throughout with discoloration, and the image was intermittent. The video connector was severely cracked and the surface of the outer tube was noted with deep scrape and indentation throughout. 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 | 9610773-2013-00021 |
| MDR Report Key | 2980230 |
| Report Source | 06 |
| Date Received | 2013-02-01 |
| Date of Report | 2013-01-04 |
| Date of Event | 2012-12-19 |
| Date Mfgr Received | 2013-01-04 |
| Date Added to Maude | 2013-04-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OLMPUS VIDEO TELESCOPES |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2013-02-01 |
| Returned To Mfg | 2013-01-08 |
| 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 | 2013-02-01 |