MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-15 for OLYMPUS VIDEO TELESCOPE WA50011A manufactured by Olympus Winter & Ibe Gmbh.
[21676497]
The user facility reported that during a laparoscopic cholecystectomy, the users experienced a complete loss of image. The procedure was completed using a different device. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[21869584]
The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report of image lost. There were multiple dents and a slight bend on the outer tube. There were scratches, dent on the frame. The video connector contact pins were corroded/burnt. The video connector was cracked. These phenomena were attributed to physical damage. The device was serviced and was returned to the user facility. 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 | 9610773-2011-00013 |
| MDR Report Key | 2068787 |
| Report Source | 06 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-03-07 |
| Date Mfgr Received | 2011-03-17 |
| Date Added to Maude | 2011-06-27 |
| 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 | 2011-04-15 |
| Returned To Mfg | 2011-03-17 |
| 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 | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-15 |