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

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Three photos were received for review.Review is in progress and not yet completed.Upon completion of photo review, a supplemental medwatch will be sent.

Event Description

It was reported that during a lap cholecystectomy the clip applier was used to ligate the duct.Clips deployed successfully on the first two firings.On the third clip deployment, the clip didn¿t deploy properly and folded in a non-symmetric manner.After that, two more clips were successfully deployed.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 12/11/2020.Additional information received: three photos were received for review.Upon visual inspection of three photos, the following was observed: the photos show a loose malformed clip from top view.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.

• 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: 10804229
• MDR Text Key: 215347386
• Report Number: 3005075853-2020-05831
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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 Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U94D5X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/12/2020
• Patient Sequence Number: 1