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

Catalog Number ER320

Device Problem Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/20/2023.D4: 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown surgery, after clipping, the clip cracked and fell.The device clipped again and there was no adverse consequence to the patient.There may have been a possibility that the harmonic1100 may have touched the clip.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2024.D4: batch # a9c56t.Investigation summary : the product was returned to ethicon  for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the er320 device was returned with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be misaligned.In addition, the packaging opened was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality; during the analysis, the instrument was cycled and it fed and formed 12 scissored clips due to the misaligned condition of the jaws; finally the instrument locked out as intended.The event reported was confirmed and it is related to improper use of the device.Possible causes for the condition found may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met before the release of this batch.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18368513
• MDR Text Key: 331298681
• Report Number: 3005075853-2023-09728
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Device Lot Number: 319C07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1