MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for LIGACLIP*ENDO LARGE APPLIER EL414 manufactured by Ethicon Endo-surgery, Llc..
[144834066]
(b)(4). Device analysis: the analysis results confirmed that the el414 device was returned nonfunctional as jaws were found to be in a yielded condition; therefore, the clips could not be loaded into the jaws. Possible causes for this condition may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel. Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use. A regular and precise visual check of the instrument should be made before each use. The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.? The certificate records are accessible through external manufacturing.?
Patient Sequence No: 1, Text Type: N, H10
[144834067]
It was reported that during a tlh procedure, product was not working. Not able to hold clip in jaws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2019-18978 |
| MDR Report Key | 8600239 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2004-04-30 |
| Date Added to Maude | 2019-05-10 |
| 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 LARGE APPLIER |
| Generic Name | APPLIER, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-04-23 |
| Catalog Number | EL414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-10 |