MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2010-04-06 for OLYMPUS TELESCOPE A22001A manufactured by Olympus Winter & Ibe Gmbh.
[1643096]
Olympus was informed of a report in which a patient sustained unspecified thermal damage to the urethra after having undergone a transurethral resection of prostate (turp) procedure. The patient reportedly complained of pain approximately 10 days after the procedure, and thermal damage of the urethra was allegedly determined by unknown means. The current condition of the patient is not known.
Patient Sequence No: 1, Text Type: D, B5
[8666389]
No devices were returned to olympus for evaluation. The devices said to have been involved in the event were forwarded to a third party for evaluation. The original equipment manufacturer (oem) was contacted for additional information regarding the report, and the oem reported that the subject telescope was part of an olympus oes pro turis resectoscope system, which was connected to a erbe electrosurgical generator during the procedure via an adapter cable. The erbe generator reportedly did not include a saline detection circuit and was therefore, not suitable for use with the oes pro turis resectoscope system. The oem followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event, but no result. The (b) (4) and (b) (4) instructions for use, both used as a part of the olympus oes pro turis resectoscope system, indicate that the devices are intended for use in saline with the (b) (4). This report is being submitted as an mdr in an abundance of caution. Cross reference mfr. Report number: 9610773-2010-00007, and 9610773-2010-00008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2010-00006 |
| MDR Report Key | 1655783 |
| Report Source | 00,01 |
| Date Received | 2010-04-06 |
| Date of Report | 2010-03-08 |
| Date of Event | 2009-11-05 |
| Date Mfgr Received | 2010-03-08 |
| Date Added to Maude | 2010-04-13 |
| 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 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 TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2010-04-06 |
| Model Number | A22001A |
| Lot Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-04-06 |