MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP II; CLIP, IMPLANTABLE

Model Number 176657

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Mechanics Altered (2984)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, while performing ligation, clips did not load properly into the jaws, clips were crisscrossed, and disengaged into the cavity of the patient.The clips were retrieved.The clip appliers were replaced to complete the case and resolve the issue.There was no patient injury.

Manufacturer Narrative

Concomitant product/s: 176657 176657 endoclip ii ml 10 appli lot/serial #:(b)(6) (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the collar under the shaft cover was bent near the jaws, and the jaws were misaligned.Functionally, when the handle was cycled to load a clip; the clip ejected from the jaws unformed.It was reported that a component disengaged from the device into the surgical cavity, the clips did not load properly into the jaws as expected, and the clips legs were malformed, crossed like a scissor.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur if the instrument is applied over an obstruction causing the jaws to misalign and damaging the component allowing the clips to eject from the device jaws unformed or malformed.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: firing a clip over another clip or other obstructions may result in bleeding and/or leakage and may damage the instrument jaws.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy procedure, while performing ligation, the two devices did not load the clips properly into the jaws, clips were crisscrossed, and disengaged into the cavity of the patient.The clips were retrieved with a grasper.The clip appliers were replaced to complete the case and resolve the issue.There was no patient injury.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14596311
• MDR Text Key: 293306217
• Report Number: 9612501-2022-00912
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J1L2703NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male