MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for LIGACLIP*ENDO MED/LG APPLIER EL314 manufactured by Ethicon Endo-surgery, Llc..
[93584284]
(b)(4). Device analysis: the el314 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition. No functional test was performed due to the condition of the applier. Possible causes for the condition found 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. It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment. 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
[93584285]
It was reported that the device was found to not be holding clips. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2017-06275 |
| MDR Report Key | 7052444 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2005-11-30 |
| Date Added to Maude | 2017-11-22 |
| 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 | 2017-11-22 |
| Returned To Mfg | 2017-10-06 |
| Catalog Number | EL314 |
| Lot Number | NA |
| 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 | 2017-11-22 |