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

Catalog Number EL5ML

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2019.Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported that a foreign matter like an insect was found in the package.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r95554.Device analysis: the analysis results found that the el5ml device was returned inside its package unopened.Upon visual inspection of the package, the foreign body was confirmed to be a cardboard box piece.Although no conclusion could be reached on how the cardboard box piece was introduced inside the sterile package, it is possible that the cardboard box piece adhered to the device during the packaging process due to static.A manufacturing record evaluation was performed for the finished device lot r95554 number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r95554 number, and no non-conformances were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8465971
• MDR Text Key: 140614773
• Report Number: 3005075853-2019-17669
• 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
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: R95554
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 04/03/2019
• Patient Sequence Number: 1