MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-28 for GENICON manufactured by Genicon.
[79145253]
During laparoscopic surgery, the genicon disposable scissor handpiece faulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070794 |
| MDR Report Key | 6686560 |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-19 |
| Date Added to Maude | 2017-07-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GENICON |
| Generic Name | GENICON DISPOSABLE SCISSOR HAND |
| Product Code | JOK |
| Date Received | 2017-06-28 |
| Lot Number | 17583-F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-28 |