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

Model Number 176630

Device Problems Image Display Error/Artifact (1304); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during first firing on a laparoscopic colorectal surgery, when the device was taken out from the blister pack, when the yellow tab was removed, it was noted that the procedure remaining was 16.When they load the clip, jaws opened a little and soon returned to the original position of opening.Accordingly, when the surgeon was trying to clip the artery, the clip didn't come out.The device was thought to be the issue and removed outside the patient's body.In addition, the device was gripped for several times, but the clip wasn't loaded, and the jaws were opened and closed without loading the clip.The counter decreased 1 count with gripping each time and worked normally.The surgical time was extended by less than 30 minutes.The procedure was completed with another device.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied.No visual abnormalities were observed with the instrument.The instrument was cycled the clip did not load, the pusher bar was observed not functioning properly.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 a manufacturing activity.The trip lever out of position was preventing the clips from loading properly.A process improvement has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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.

Manufacturer Narrative

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 18750 ; DO 18750
• MDR Report Key: 8803015
• MDR Text Key: 151451292
• Report Number: 9612501-2019-01406
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057859
• UDI-Public: 20884521057859
• 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,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J8E0398X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1