MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-13 for LIGACLIP* APPLIER W/MECH STOP LX107 manufactured by Ethicon Endo-surgery, Llc..
[188420719]
(b)(4). Attempts are being made to retrieve the device. To date, the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. The device history records were reviewed and "certed" by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.
Patient Sequence No: 1, Text Type: N, H10
[188420720]
It was reported that during a revascularization of the myocardium procedure, according to the medical report, the lx107 ligaclip applicator was defective. Due to the appearance of the misalignment of its tips, it caused a cut in the blood vessel at the time of clipping. With the replacement of the ligaclip applicator, the procedure was continued without complications. Patient consequence was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2020-00991 |
| MDR Report Key | 9706989 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-13 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGACLIP* APPLIER W/MECH STOP |
| Generic Name | APPLIER, SURGICAL, CLIP |
| Product Code | GDO |
| Date Received | 2020-02-13 |
| Catalog Number | LX107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-13 |