MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number ER420

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that prior to an unknown procedure, both devices the clips bifurcated during the first trial fire, after taken out of the package.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the er420 device was returned in good condition with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be in good condition.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed, retained and formed the remaining clips as intended.The reported event could not be confirmed as the device was found to be fully functional.No conclusion could be reached as to what may have caused the reported incident.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: LIGACLIP ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4405260
• MDR Text Key: 5433811
• Report Number: 3005075853-2015-00274
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1