MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER420

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is unknown.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information: what procedure were they performing? how was the procedure completed? was there any patient consequence? if yes: please explain: how was the patient consequence resolved? to date, no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, the item was opened and used during surgery and during use, the clips were crossing over and not functioning as they should.It is unknown how procedure was completed and patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 1/29/2020.D4: batch # t93l4d.Investigation summary : the analysis results found that the er420 device was returned with no damage in the external components and with a clip in the jaws.The clip was removed in order to inspect the jaws and they were found with no damage.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed, retained and formed the remaining 9 clips as intended.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.In addition, a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a device, jaw area of device from top view, and there is a loose clip, that is not properly formed, that is near the jaws of the device.Based on the photo alone the event described is confirmed, however no conclusion or root cause could be determined.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Additional information received: what procedure were they performing? it was a lap chole.How was the procedure completed? another device was opened and used.Was there any patient consequence? no.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9506956
• MDR Text Key: 194817264
• Report Number: 3005075853-2019-24690
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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 Expiration Date: 05/19/2024
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: T94C6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 01/08/2020
• Supplement Dates FDA Received: 01/29/2020; 01/29/2020
• Patient Sequence Number: 1