MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-02-06 for OLYMPUS CYSTOSCOPE UNK manufactured by Olympus Medicla System Scorporation.
[3187835]
Olympus received a medwatch report, which stated: "storz light cord was in a olympus cystoscope set. The cord is not compatible with the scope. Can be made to fit with an adapter, but temperature is not the same in the light, and pt could potentially be burned. Issue was discovered prior to use in pt and a correct cord was found and used, so no harm. It is imperative that the brand and number on cords be checked when assembling sets - both light cords are grey and look very similar, but are not interchangeable. There are several models of light cords with similar connector (or can make to connect to other light source). Potential for misconnections. The original intended procedure was laser lithotripsy, ureteroscopy. "
Patient Sequence No: 1, Text Type: D, B5
[10571114]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reported that the storz light cord looked very similar to the olympus light cord that came with the cystoscope set as both were grey and could be mixed up easily per the user facility. The user facility indicated that the storz light cord was not part of the accessory that came with the referenced device's original package. There were no further details provided on the referenced device's model and serial numbers. Per the user facility, the referenced device was still in circulation. The device referenced in this report was not returned to olympus for evaluation. Based on the information provided by user facility, there did not appear to be any device malfunction nor was there any pt injury. The reported phenomena appeared to be related to user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2013-00039 |
| MDR Report Key | 2969513 |
| Report Source | 00,06 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-01-11 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2013-01-11 |
| Date Added to Maude | 2013-03-05 |
| 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 | 0 |
| 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 MEDICAL SYSTEM CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS CYSTOSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | GCQ |
| Date Received | 2013-02-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| 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 MEDICLA SYSTEM SCORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-06 |