MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-01 for OLYMPUS A5609 * manufactured by Olympus Winter & Ibe Gmbh.
[21383166]
The physician reported that there was sparking from the insulation near the tip of the device during a laparoscopic cholectomy procedure that was performed in 2000. A video was provided by the physician illustrating this procedure and device sparking. The physician also reported that there was a chip in the insulation at the tip of the device. There was no allegation of harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[21474287]
The device in question was not returned to olympus for investigation. However, there was an obvious sparking that occurred as seen on the video and a break in the insulation at the tip of the device was also noted in the video. This break in the insulation would cause the sparking to occur as seen in the video. The original equipment manufacturer states that using spray high frequency applications when using a spoon electrode can also cause sparking. In the device instruction manual, the user is instructed to inspect the device for broken insulation or other potential damage prior to use. The instruction manual also recommends replacement if such deformities or abnormalities are found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2006-00004 |
| MDR Report Key | 725727 |
| Report Source | 05,06 |
| Date Received | 2006-06-01 |
| Date of Report | 2006-03-01 |
| Date of Event | 2000-10-14 |
| Date Added to Maude | 2006-06-14 |
| 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 | 3 |
| 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 | 6318445688 |
| 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 | SPATULA ELECTRODE |
| Product Code | EWY |
| Date Received | 2006-06-01 |
| Model Number | A5609 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 713957 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | * HAMBURG GM |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | SPATULA ELECTRODE |
| Baseline Model No | A5609 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-01 |