MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-02 for OLYMPUS A50001A manufactured by Olympus Winter & Ibe Gmbh.
[827377]
The user facility reported that during a therapeutic laparoscopic cholecystectomy, a complete loss of image was experienced. The procedure was completed with a different, but similar telescope and video cart. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7994810]
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. The device was evaluated, and no image loss was observed. There were minor dents noted on the outer tube at the distal end and video connector, and approximately twenty percent of the light guide bundle fibres were broken. The cause of the user's experience cannot be conclusively determined, however the physical findings of the investigation are consistent with physical damage. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2008-00012 |
| MDR Report Key | 1025670 |
| Report Source | 05,06 |
| Date Received | 2008-04-02 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-03-07 |
| Date Added to Maude | 2009-01-27 |
| 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 |
| Generic Name | VIDEO TELESCOPE, 10MM |
| Product Code | FBP |
| Date Received | 2008-04-02 |
| Model Number | A50001A |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2008-04-02 |