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 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information received: two photos were received for review.Upon visual inspection of the two photos, the following was observed: the first photo shows a device from jaw area and it can be seen closed.The second photo shows five clips not properly formed inside of a plastic bag.Based on the photos reviewed, the event described is confirmed, however, no conclusion or root cause could be determined as no device was received.If the device is received at a later date, hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Event Description

It was reported that during an unknown procedure, after the third fire, the clip malformed.Changed to a new device to complete surgery.There was no patient consequence reported.No additional information can be provided.

Manufacturer Narrative

(b)(4).Date sent: 5/14/2020.D4: batch # t94l96.H2: additional information received: additional information was received that confirmed the alert date was 4/3/2020.H10=corrected data=b4 b4.Date of this report for 3005075853-2020-02406 should have been 4/3/202 and not 4/2/2020, thus report submission due date should have been 5/3/2020 for 3005075853-2020-02406 instead of 5/2/2020.Investigation summary the analysis results found that the el5ml device was returned with no apparent damage.In addition 7 malformed clips were received inside of a plastic bag.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 3 conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch 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: 10008183
• MDR Text Key: 194347065
• Report Number: 3005075853-2020-02406
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: T94L96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 04/29/2020
• Patient Sequence Number: 1