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

Model Number ER320

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); No Apparent Adverse Event (3189)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "the sales rep checked the device on (b)(6).The sales rep fired the device, malformed clip came out.The remaining clip turned 0, and the device locked out." 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 a laparoscopic mile¿s operation, two clips came out together after 9th firing.Two clips were retrieved, and attempted to fire the device again, but the clip did not close and fell off.The same issue occurred for the next clip as well.In total, four clips would not close properly.The patient was severely obese and has a medical history of cerebral infarction.Slight bleeding occurred, and a blood transfusion was not performed.No adverse consequences to the patient.Another device was used to complete the case.

Manufacturer Narrative

(b)(4).Date sent: 2/9/2023.D4: batch # x95m3p.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 for analysis and upon inspection, the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident, the device was functionally evaluated.Upon firing of the device it was noted to be empty and locked out.The instrument is designed to lock out after all the clips have been fired; therefore a potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.It is known from the history of the device that the condition of the jaws may lead to dropping/ejected clips.The event reported was confirmed and it is related to improper use of the device.Possible causes for the found condition of the yielded jaws maybe 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.Please reference the instruction for use for more information.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch x95m3p 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: 16137843
• MDR Text Key: 308627499
• Report Number: 3005075853-2023-00245
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 01/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1