MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for LIGACLIP*ENDO LARGE APPLIER EL414 manufactured by Ethicon Endo-surgery, Llc..
[101009021]
(b)(4). Only event year known: 2018. Additional information was requested and the following was obtained: can you please clarify, when the clips "chipped from the applier" did the clips fall out of the jaws? Please provide further detail of the event. Response: i talked to a few scrubs,? Chipped from applier? Should be? Slipped from the applier? Which to us means the clip fell out of the applier before it could be used. Device analysis: the analysis results found that the el314 device was received with no apparent damage. In an attempt to replicate the reported incident, the device was tested for functionality. Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended. The instrument was fully functional and conforming to our manufacturing requirements. No conclusion could be reached as to what may have caused the reported incident. The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.?
Patient Sequence No: 1, Text Type: N, H10
[101009022]
It was reported that the clips chipped from the applier and don't clip tight. This was discovered during testing. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2018-08168 |
| MDR Report Key | 7293085 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-30 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2009-02-28 |
| Date Added to Maude | 2018-02-23 |
| 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 | LIGACLIP |
| Product Code | HBT |
| Date Received | 2018-02-23 |
| Returned To Mfg | 2018-02-12 |
| 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 | 2018-02-23 |