MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-03 for OMNICLOSE TROCAR SITE CLOSURE NEEDLE FCL201100 manufactured by Unimax Medical Systems Inc.
[92211993]
The dhr for the product in question was reviewed and found without any irregularities. It is unclear under what circumstances could the device cut the suture considering the structure and operation principle of the device. The structure of the grasping jaws are rounded without sharp edges. The operation principle is to grasp the suture and hold it in the loop created by the jaws instead of firmly clipping it. A review of the record indicates that there is no similar issue since the product is launched. The event will be closed. If the additional information could be obtained for further investigation, the supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92211994]
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 | 3007791595-2017-00012 |
| MDR Report Key | 6998588 |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-09-13 |
| Date Added to Maude | 2017-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 2017-11-03 |
| Model Number | FCL201100 |
| Catalog Number | FCL201100 |
| Lot Number | 8101705035 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNIMAX MEDICAL SYSTEMS INC |
| Manufacturer Address | 8F-2, NO 127, LANE 235 PAO CHIAO R, HSIN TIEN DIST. TAIPEI CITY, 23145 TW 23145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-03 |