MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for NEPTUNE SMOKE EVACUATION PENCIL 0703-047-000 manufactured by Stryker Instruments.
[183796771]
On (b)(6) 2020 pt was taken to the operating room for a cesarean section to deliver twin gestation (b)(6) weeks 5 days. The subcutaneous tissue was mitigated and small bleeders cauterized with the neptune smoke evacuation pencil. The tip of the equipment started to melt. On 02/21/2020 inspection of the valleylab force fx electrosurgical unit, biomet id#sl-n0322773, serial # (b)(4), se# (b)(4) was tested, outputs were found to be within normal spec using bc group esu-2300 electrosurgical analyzer. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093761 |
| MDR Report Key | 9834854 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEPTUNE SMOKE EVACUATION PENCIL |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2020-03-13 |
| Catalog Number | 0703-047-000 |
| Lot Number | 1934001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | KALAMAZOO MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |