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

Model Number 176630

Device Problems Display or Visual Feedback Problem (1184); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on the first firing during a laparoscopic cholecystectomy, the activation tab was removed but the clip counter did not indicate.It was stated that one clip was fired, but the handle did not return to its initial position.The use of the clip applier was stopped and the procedure was completed by using a new product.There was no patient injury.

Manufacturer Narrative

Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received with twelve clips remaining.Functional testing found the instrument to cycle without binding.Clips loaded into the jaws, formed properly, released from the jaws and remained securely attached to test media.When the cartridge was empty, the interlock engaged to prevent the jaws from approximating.The clip counter was no longer active upon receipt of the instrument.The handle was disassembled for visualization of internal components.Upon inspection of the counter housing, it was noted particulates were present within the counter contact area, preventing activation of the counter light upon removal of the yellow tab.The particulate was removed from the counter contact area and the counter energized.The returned counter indexed properly without issue.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of particulate matter; this was identified as a quality issue with a component obtained from a third party supplier and a product improvement has been initiated to track this failure mode.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.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 9355518
• MDR Text Key: 167402019
• Report Number: 9612501-2019-02254
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Combination Product (y/n): N
• PMA/PMN Number: K100242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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 Expiration Date: 11/30/2021
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J8M1784Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1