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 2007-12-28 for OLYMPUS A22002A manufactured by Olympus Winter & Ibe Gmbh.
[773125]
The user facility reported that the tip of the telescope and a lazer device was noted to be burnt during a transurethral resection of prostate (turp). The facility's staff reported that the attending physician was using a homien laser with the telescope at the time of use. The model, serial number and the manufacturer of the laser device used with the telescope are unknown. The facility's staff indicated that the procedure was completed with the same telescope. There was no allegation of patient harm, and there was no complication reported.
Patient Sequence No: 1, Text Type: D, B5
[7896146]
The device referenced in this report was returned to olympus for investigation. The evaluation confirmed evidence of thermal damage to the distal tip of the telescope. Moisture and fluid were noted inside the objective cover glass. There were also broken fibers and sharp edges observed which were determined to be due to physical damage. Additionally, there was deep scrape and bend noted on the outer tube, which was attributed to user handling. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2007-00028 |
| MDR Report Key | 970626 |
| Report Source | 00,05,06 |
| Date Received | 2007-12-28 |
| Date of Report | 2007-11-30 |
| Date Added to Maude | 2008-04-09 |
| 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 | TELESCOPE |
| Product Code | FBP |
| Date Received | 2007-12-28 |
| Model Number | A22002A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 973585 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | HAMBURG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-28 |