MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for ASSI manufactured by Accurate Surgical Scientific Instruments Corporation.
[185223687]
Patient having bilateral augmentation mastopexy and bilateral lateral thigh liposuction. Utilizing lighted mammoplasty retractor with light source. Light source overheated with smell of burning plastic and smoking. End of light cord slighted blackened in color. Both items removed from operating room and replaced other light source and retractor with no subsequent issues. Light source to be checked out by biomed and lighted retractor sent to sterile processing for decontamination prior to also being checked by biomed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888462 |
| MDR Report Key | 9888462 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-06 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | ASSI |
| Generic Name | LIGHT SOURCE, FIBEROPTIC, ROUTINE |
| Product Code | FCW |
| Date Received | 2020-03-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCURATE SURGICAL SCIENTIFIC INSTRUMENTS CORPORATION |
| Manufacturer Address | 300 SHAMES DR. WESTBURY NY 11590 US 11590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |