MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-06 for HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON" WA22566S manufactured by Olympus Winter & Ibe Gmbh.
[177977275]
The device was not returned for evaluation. The cause of the reported event cannot be determined. As part of our investigation, a sales representative will be going to the customer? S site the next time cases are scheduled to ensure they are provided with all the possible information and training again.
Patient Sequence No: 1, Text Type: N, H10
[177977276]
The service center was informed that during a trans urethral vaporization of prostate (turp) procedure, the anesthetist was overcome by fumes during plasma button use and complained of pleuritic pain for three days following the incident. It was reported that the odor in the operating theatre was much stronger than normal for plasma button use. The odor occurred with two of facility? S new surgeons. The intended procedure was completed with same device. The anesthetist did not seek medical treatment and recovered at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2020-00065 |
| MDR Report Key | 9676408 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-06 |
| 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 | 3 |
| Manufacturer Contact | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON" |
| Generic Name | HF-RESECTION ELECTRODE |
| Product Code | FAS |
| Date Received | 2020-02-06 |
| Model Number | WA22566S |
| Catalog Number | WA22566S |
| Lot Number | UNKNOWN |
| 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, HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |