MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2008-09-16 for OLYMPUS A50021A manufactured by Olympus Winter & Ibe Gmbh.
[21989467]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's claim of image loss. The outer tube was noted to be severely bent and had multiple dents on the exterior of the outer tube, including some near the location of charge coupler device (ccd). There were additional dents on the light guide cable and video connector, a small cut on the light guide cable, and the unit failed light transmission testing. The cause of the user's experience was attributed to physical damage, likely due to user handling. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[22189696]
The user facility reported that during a therapeutic laparoscopic hysterectomy, the image was lost and could not be recovered. The device was completed with a different, but similar device. There was no allegation of patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2008-00027 |
| MDR Report Key | 1165723 |
| Report Source | 00,05,06 |
| Date Received | 2008-09-16 |
| Date of Report | 2008-08-19 |
| Date Added to Maude | 2009-02-23 |
| 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 |
| Generic Name | VIDEO TELESCOPE |
| Product Code | FBP |
| Date Received | 2008-09-16 |
| 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 | HAMBURG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-16 |