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

Model Number 176630

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2019

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 set up pre-operatively, the jaws of the clip applier got malformed and broken.Another device was used to resolve the issue.There was no patient involvement.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.The instrument was received partially fired with four clips remaining.Visual inspection of the instrument noted that one of the jaw legs was out of position.The cam on the jaw leg was not aligned with the driver.Further inspection noted the handle was flaccid and not attached to the internal components.Functionally, the instrument was dismantled for visualization of internal components which revealed that the wishbone link which attaches the trigger to the firing mechanism had disengaged.The wishbone link was reattached to the trigger handle and the instrument was reassembled.The jaw leg was then reset by aligning the cam with the driver.The instrument was applied to test media.The remaining clips loaded into the jaws, formed properly, released from the jaws and remained securely attached to test media.The interlock engaged after all clips were dispensed to prevent the jaws from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the disengaged jaw cam condition may occur when one of the jaws legs gets forcefully pulled outward away from the center line of the shaft.The noted jaw cam disengagement impedes functionality of the jaws, possibly resulting in clip malformation and/or difficulty removing the instrument from a trocar.Replication of the disengaged wishbone link condition may occur if the handle is forcefully pulled open prior to fully completing the full handle compression.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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,ct 0101 ; DO 0101
• MDR Report Key: 9176986
• MDR Text Key: 183257155
• Report Number: 9612501-2019-01946
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J8K1706X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1