MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-08 for HF-RESECTION ELECTRODE PLASMALOOP ? MEDIUM, 30 DEG, 24 FR WA47506S manufactured by Olympus Winter & Ibe Gmbh.
[132622491]
The device has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To mitigate against general device breakage, the device instructions for use warns against bending the distal tip. The instructions for use also have pre-procedure directions for inspecting both the device and its packaging for damage and deformation. The instructions for use also recommends that the stored device not be exposed to sunlight or have its packaging crushed by surrounding objects.
Patient Sequence No: 1, Text Type: N, H10
[132622492]
Olympus was informed that during an unspecified procedure, the tip of the device detached inside the patient. The detached tip was retrieved using an unknown means. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00340 |
| MDR Report Key | 8229981 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-08 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-RESECTION ELECTRODE PLASMALOOP ? MEDIUM, 30 DEG, 24 FR |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2019-01-08 |
| Model Number | WA47506S |
| Catalog Number | WA47506S |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-08 |