MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-06-22 for OLYMPUS TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.
[2705689]
The user facility reported that at the start of the transurethral resection of prostate (turp) procedure, the image was very good, but after ten minutes in the procedure, the user experienced complete loss of image on the monitor. The user withdrew the telescope to be cleaned and then reinserted the telescope to the pt, but there was still no image on the monitor. The procedure was completed using a monopolar system. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9972323]
Olympus followed up with the user facility to obtain add'l info regarding the report, but with no result. The subject device was returned to olympus for evaluation. The evaluation revealed that the image was dark and blurry, which impaired good visualization. The image difficulty was attributed to a bent outer tube and broken optical system lens. The device will be 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 | 9610773-2012-00032 |
| MDR Report Key | 2639505 |
| Report Source | 01,08 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-05-25 |
| Date Mfgr Received | 2012-05-25 |
| 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 |
| 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 |
| Manufacturer Country | GM |
| 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 | 2012-06-22 |
| Returned To Mfg | 2012-06-01 |
| Model Number | A22002A |
| Catalog Number | A22002A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-22 |