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

Catalog Number ER420

Device Problem Failure to Form Staple (2579)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, clip was scissoring occurred.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: 2/22/2024.D4: batch # unk.Additional information was requested and the following was obtained: "the device was used on the gastrectomy.There was no bleeding, leakage nor damage on tissue due to the clip issue.The patient is stable after the operation." 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.

Manufacturer Narrative

(b)(4).Date sent: 3/19/2024.D4: batch # a9ct9x.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 er420 device was returned and upon inspection the jaws were found to be in a misaligned condition.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 eight(8) 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.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18763896
• MDR Text Key: 336427488
• Report Number: 3005075853-2024-01565
• Device Sequence Number: 1
• Product Code: FZP
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER420
• Device Lot Number: A9CT9X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1