MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-05-23 for OLYMPUS WA50011A manufactured by Olympus Winter & Ibe Gmbh.
[863712]
The user facility reported that during a therapeutic laparoscopy, a complete loss of image was experienced. The procedure was reportedly completed with a different, but similar device and there was no patient injury. No further information was provided by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[8085749]
The device referenced in this report was returned to olympus for investigation. The investigation did not duplicate the user's report of a complete loss of image. However, the image was observed to be slightly dark, and the unit failed the light transmission test. The investigation noted large dents on the outer tube. Additionally, dents were noted on the light guide adapter and video connector plug and scratches were found on the outer tube, distal end, and video connector plug. The cause of the user's experience cannot be conclusively determined, however, the physical damage found on the device cannot be ruled out as a contributing factor to the reported event. This report is being filed as medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2008-00016 |
| MDR Report Key | 1052379 |
| Report Source | 06 |
| Date Received | 2008-05-23 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-24 |
| Date Added to Maude | 2010-04-06 |
| 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 |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2008-05-23 |
| Model Number | WA50011A |
| 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 | HAMBURG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-23 |