MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-05 for OLYMPUS TELESCOPE A50021A manufactured by Olympus Winter & Ibe Gmbh.
[18415719]
The user facility reported that during a therapeutic laparoscopic cholecystectomy, the image was lost. The videoscope was withdrawn from the pt and the procedure was completed using a different but similar device. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18677856]
The device was returned to olympus for eval. The eval was not able to confirm the user's report. However, the user facility returned a picture captured during the use of the subject device; the picture appeared smeared and with no visualization. This type of image issue is indicative of fluid on the video connector. There were minor dents noted on the outer tube and on the distal end of the video connector. The light guide fiber on the light guide cable was sunk, the video cable was buckled and the light transmission test failed, the image difficulty was attributed to a damaged light guide cable. The subject device was serviced and 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 | 9610773-2012-00102 |
| MDR Report Key | 2748113 |
| Report Source | 06 |
| Date Received | 2012-09-05 |
| Date of Report | 2012-08-17 |
| Date of Event | 2012-08-17 |
| Date Mfgr Received | 2012-08-17 |
| Date Added to Maude | 2012-10-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | KUEHNSTRABE 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 | 2012-09-05 |
| Returned To Mfg | 2012-08-20 |
| Model Number | A50021A |
| Catalog Number | A50021A |
| 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 | KUEHNSTRABE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-05 |