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

Model Number EL5ML

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u94535.Investigation summary: the analysis results of the el5ml found that the device was received with one jaw broken at bifurcation.The device was disassembled and evidence of corrosion was found throughout the broken area.Nine remaining clips were found on the clip track.The most likely reason for jaw bifurcation 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 issue, 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 lot/batch number and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, one of the prongs broke off while being used.All pieces were retrieved.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10445198
• MDR Text Key: 204362799
• Report Number: 3005075853-2020-04285
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U94535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1