MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-13 for OLYMPUS TELESCOPE WA50011A manufactured by Olympus Winter & Ibe Gmbh.
[14889087]
Olympus was informed that at the beginning of a therapeutic laparoscopic cholecystectomy, the users experienced complete loss of image. The procedure was completed using a different laparoscope flexible camera. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[15292878]
The subject device referenced in this report was returned to olympus for evaluation. The evaluation was able to duplicate the user's report of image loss. The image was found to be distorted, and the telescope has multiple dents on the outer tube, and on the frame. Additionally, the light guide lens was cracked. The image difficulty was isolated to a damaged cable unit. The device was serviced and returned to the user facility. The cable unit was forwarded to the original equipment manufacturer (oem) for further investigation. If significant and relevant information is received later, this report will be updated. 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 | 9610773-2011-00026 |
| MDR Report Key | 2300617 |
| Report Source | 06 |
| Date Received | 2011-10-13 |
| Date of Report | 2011-09-15 |
| Date Mfgr Received | 2011-09-15 |
| Date Added to Maude | 2012-03-16 |
| 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 AVENUE |
| 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 TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2011-10-13 |
| Returned To Mfg | 2011-09-16 |
| Model Number | WA50011A |
| Catalog Number | WA50011A |
| 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 | 2011-10-13 |