MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-04-05 for OLYMPUS TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.
[2592702]
The user facility reported that during the first ten mins of a therapeutic transurethral resection of the prostate (turp) procedure, the video image was very clear; however, after ten mins of surgery the user experienced a complete loss of image on the monitor. The procedure was stopped, and the users switched to rtu monopolar device to complete the procedure. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9858164]
The device referenced in this report was returned to olympus for eval. The eval confirmed that the image was severely dark and hazy, but the image was slightly visible. The proximal end of the outer tube was bent with minor scratches, which likely caused the optical lens inside the outer tube to break, which likely caused the user's experience. This phenomenon was attributed to mishandling. The device will be refurbished. 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 | 9610773-2012-00014 |
| MDR Report Key | 2539086 |
| Report Source | 01,08 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-07 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-09-07 |
| 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 | 2012-04-05 |
| Returned To Mfg | 2012-03-19 |
| Model Number | A22002A |
| Catalog Number | A22002A |
| 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 | 2012-04-05 |