MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for cautery pencil 0703-047-000 manufactured by Stryker.
[96176559]
Cut and coagulation functions on pencil appeared to be reversed and patient sustained small burn next to incision site, during spine surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074278 |
| MDR Report Key | 7154341 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-12-12 |
| Date Added to Maude | 2017-12-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | cautery pencil |
| Generic Name | ESU |
| Product Code | GEI |
| Date Received | 2017-12-28 |
| Catalog Number | 0703-047-000 |
| Lot Number | 1729035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Brand Name | NEPTUNE SMOKE EVACUATOR |
| Generic Name | APPARATUS, EXHAUST, SURGICAL |
| Product Code | FYD |
| Date Received | 2017-12-28 |
| Catalog Number | 0703-047-000 |
| Lot Number | 1729035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-28 |