MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for LIGACLIP*ENDO MED/LG APPLIER EL314 manufactured by Ethicon Endo-surgery, Llc..
[107197713]
(b)(4). The batch was not provided; therefore, the manufacturing records could not be reviewed. Additional information was requested and the following was obtained: did the clip cut the vessel? Yes. Was there any change in the post-operative care of the patient as a result of the event? No.
Patient Sequence No: 1, Text Type: N, H10
[107197714]
Could not close clip. During the simple excision of left milk surgery, could not close the clip. The patient was bleeding. Another device was used to stop bleeding and complete the surgery. The patient is stable and left from hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2018-09461 |
| MDR Report Key | 7475325 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-13 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGACLIP*ENDO MED/LG APPLIER |
| Generic Name | LIGACLIP |
| Product Code | HBT |
| Date Received | 2018-05-01 |
| Catalog Number | EL314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |