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

Catalog Number EL5ML

Device Problems Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t92d9t.Device analysis: the analysis results found that an el5ml device was returned inside its package unopened.Upon visual inspection, a foreign matter was noted to be inside and was confirmed to be flash from the device.In addition, the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was noted to be from the outside in.During manufacturing/testing in some cases component friction can result in small shavings ejecting from the device after packaging during transit.The reported complaint was confirmed.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.A manufacturing record evaluation was performed for the finished device lot: t92d9t number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch: t92d9t number, and no non-conformances were identified.

Event Description

It was reported that before an unknown procedure, a foreign matter was found inside the package before the package was opened.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.Further information is available.

Manufacturer Narrative

(b)(4).Per photographic evaluation: upon visual inspection of four photos, the following was observed: the first and fourth photo show an unopened packaged from top view of tyvek and a damage can be seen from outside to inside; indicating an improper handling of the package and belong a product code el5ml with lot # t9d9t, exp.Date 2024-01-31.The second and third photos show a black foreign matter inside of the sealed packet from top view.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.

• 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: 8812983
• MDR Text Key: 152031314
• Report Number: 3005075853-2019-20614
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: EL5ML
• Device Lot Number: T92D9T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Date Manufacturer Received: 07/08/2019
• Patient Sequence Number: 1