MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for OMNICLOSE TROCAR SITE CLOSURE NEEDLE FCL201100 manufactured by Unimax.
[86459065]
The unimax omniclose trocar site closure needle cut the suture when used to grasp the suture and bring it up through the skin. When the graspers were closed and pulling the suture in, it cut through the suture instead of grasping it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072157 |
| MDR Report Key | 6868401 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-09-13 |
| Date Added to Maude | 2017-09-15 |
| 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 |
| 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 | OMNICLOSE TROCAR SITE CLOSURE NEEDLE |
| Generic Name | TROCAR SITE CLOSURE |
| Product Code | GDF |
| Date Received | 2017-09-14 |
| Model Number | FCL201100 |
| Catalog Number | FCL201100 |
| Lot Number | 8101705035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNIMAX |
| Manufacturer Address | HSEN TIEN, TAIPEI TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |