MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.Batch # r92812.Device analysis: the analysis results of the el5ml found that the device was received with the jaw broken and the jaw was not returned for analysis.The device was disassembled and evidence of corrosion was found throughout the broken area.3 remaining clips were found on the clip track.The most likely reason for jaw breakage is stress corrosion cracking and the most likely root cause is exposure to a solution containing chlorine.The reported complaint was confirmed.In addition, in order to avoid this kind of issues please do not reuse, reprocess or re sterilize device.Reuse, reprocessing or re sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness or death.A manufacturing record evaluation was performed for the finished device batch r92812 number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the clip was not advancing.There were no patient consequences.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8559992
• MDR Text Key: 143869854
• Report Number: 3005075853-2019-18528
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1