MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-22 for 01-0350 manufactured by Electro Surgical Instrument Company.
[3216511]
Fiber optic cable connected to retractor, shut off after procedure and laid on patient. Blister noted on left breast post procedure. Cable sent to manufacturer and found to be in good condition and able to be put in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028726 |
| MDR Report Key | 2932296 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-14 |
| Date of Event | 2013-01-02 |
| Date Added to Maude | 2013-01-30 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FIBER OPTIC CABLE |
| Product Code | FDG |
| Date Received | 2013-01-22 |
| Model Number | 01-0350 |
| Lot Number | 061056 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTRO SURGICAL INSTRUMENT COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-22 |