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

Model Number ER320

Device Problems Failure to Form Staple (2579); Failure to Fire (2610)

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

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4); batch #: unk.The lot/batch was not provided, therefore, a manufacturing record evaluation could not be performed.Attempts are being 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.

Event Description

It was reported that during a sleeve gastrectomy procedure, the device jammed, and fired cross clips.It is unknown how procedure was completed.There was no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 1/4/2021.D4: batch # u93d67.H6: component code: mechanical (g04) investigation summary the analysis results found that the er320 device was returned with three clips jammed inside the shroud.Due to this condition, no further testing could be performed.In addition, a crack was noted on the cover and nineteen clips were found inside clip track.No conclusion could be reached as to what may have caused the reported incident.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: fully squeeze the trigger and then release to load the first clip into the instrument jaws.Failure to completely squeeze the trigger can result in clip mis-loading.Position the jaws with the clip completely around the vessel to be ligated.Fully squeeze the trigger on each firing.Do so by pulling back on the trigger even after a sharp ¿click¿ is heard and until you touch plastic trigger to plastic handle (plastic to plastic).Fully release the trigger after firing.A second ¿click¿ should be heard indicating the instrument is ready for the next firing.The next clip is automatically advanced as the trigger is released.Inspect the instrument jaw tips after each use to ensure a new clip is present before the next firing." it should be noted that as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10837674
• MDR Text Key: 216414670
• Report Number: 3005075853-2020-05992
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• 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
• Report Date: 10/27/2020

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: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 01/04/2021
• Patient Sequence Number: 1