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

Model Number 176625

Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, clip dropped while the nurse opened the device.It was also noted that there were clips malformed.The surgeon changed another clip to resolve the issue.The event happened during a procedure but the device was not used in patient.

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 partially applied with four remaining clips.During functional evaluation, it was observed that the jaws would not close upon actuation of the handle.The instrument body was removed from the shaft and disassembled for visualization of internal components.It was observed that the firing handle linkage was forced through the channel tube lugs, suggesting that the instrument had been fired through the safety interlock.Due to the noted damage, further functional testing of the instrument could not be performed.In addition; the interlock mechanism was triggered as a result of rapidly actuating the handles of the device and or forcing the device, this renders the device inoperable and poses no harm to the patient.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 this condition may occur when an attempt is made to fire the instrument without first loading a clip by using the trigger.The safety interlock feature is designed to prevent the jaws from closing on a vessel in the absence of a loaded clip.If an attempt is made to forcibly fire the instrument while engaged in interlock, the lugs are designed to break as noted and the interlock feature continues to function as intended.No further actions have been deemed necessary at this time.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.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
• 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: 9309590
• MDR Text Key: 182921113
• Report Number: 9612501-2019-02182
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• PMA/PMN Number: K954435
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 176625
• Device Catalogue Number: 176625
• Device Lot Number: J9A1267NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1