MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-30 for OLYMPUS VIDEO TELESCOPE A50021A manufactured by Olympus Winter & Ibe Gmbh.
[1835351]
The user facility reported that during an unspecified type of laparoscopy procedure, the user experienced a complete loss of image. The procedure was reportedly completed with a different, but similar device and there was no pt injury. No further detailed info was provided by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[8920075]
The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report of image difficulty. The device was tested and there was no image found. The outer tube was bent, had multiple dents and scratches, which likely contributed to the image difficulty. There were dents on the objective lens, and on the video connector. The meniscus lens was cracked. The light guide cable unit was buckled below the protector boot on the control body side, and the contact pins were corroded. The cause of the user's experience was attributed to a damaged outer tube. Based upon the results of the investigation, the cause of the reported phenomenon was likely due to user handling. This report is being filed as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2010-00032 |
| MDR Report Key | 1880111 |
| Report Source | 05,06 |
| Date Received | 2010-09-30 |
| Date of Report | 2010-09-03 |
| Date of Event | 2010-09-03 |
| Date Mfgr Received | 2010-09-03 |
| Date Added to Maude | 2011-02-02 |
| 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 | TELESCOPE |
| Product Code | FBP |
| Date Received | 2010-09-30 |
| Returned To Mfg | 2010-09-14 |
| Model Number | A50021A |
| Lot 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 | 2010-09-30 |