MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-26 for LIGACLIP EL214 manufactured by Ethicon Endo-surgery, Llc..
[89411560]
(b)(4). Device analysis: the el214 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition. Upon testing, the device loaded and retained the clips as intended; however, the clips were not properly formed due to the condition of the jaws. 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 themanufacturing criteria was met prior to the release of the equipment. Additional information was requested and the following was obtained: how did the device malfunction? The device would not hold clips when being loaded on the back table. Were the jaws misaligned? They said jaws were perpendicular to cartridge when loading. Did the device not hold a clip in the jaws? Yes. Clip would not stay in jaws. Did the device jaws not close? Jaws did not close when clip was attempting to be loaded. With no clip, jaws close. Did the device not close the clip (firing issue)? The clip could not be loaded to get to this step. Did the device deploy a malformed clip (unformed, malformed, scissored, etc. )? Unformed.
Patient Sequence No: 1, Text Type: N, H10
[89411561]
It was reported that during an unknown procedure, the clip applier open and malfunctioned. Another like device was used to complete the procedure. There were no adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2017-04851 |
| MDR Report Key | 6893902 |
| Date Received | 2017-09-26 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-09-09 |
| Date Added to Maude | 2017-09-26 |
| 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 |
| Generic Name | LIGACLIP |
| Product Code | HBT |
| Date Received | 2017-09-26 |
| Returned To Mfg | 2017-08-22 |
| Catalog Number | EL214 |
| 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 | 2017-09-26 |