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

Model Number 176657

Device Problems Fail-Safe Problem (2936); Mechanics Altered (2984)

Patient Problems Hemostasis (1895); Tissue Damage (2104); No Code Available (3191)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic procedure, upon clipping of the arteries and veins of the gallbladder and liver, surgeon was not able to squeeze the handle and there was issue experienced with the loading/firing the clips.The clip applier jammed and coagulation needed to be done in order to prevent hemorrhage because clip did not deploy.The damage tissue was treated with hemostasis using a different clip applier.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with sixteen 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 was not performed.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 broken firing linkage condition may occur under the following conditions: 1) when the firing handle has not been allowed to fully return to the home position after forming a previous clip.2) a single continuous handle compression is one of two firing methods described in the information booklet which accompanies each product shipment, if the handle is compressed at an accelerated rate, clips do not have enough time to enter the jaws and the instrument will lock preventing the jaws from closing without a clip.The instructi ons for use (ifu) warns to confirm that the clip is positioned within the jaws and is free of other clips or obstructions before squeezing the handle top close the clip.However, rather than forceful compression of the firing handle under these circumstances, if the firing handle is fully released by relieving hand pressure, the interlock feature will disengage, the next clip will load, and the clip can be applied.Furthermore; if an attempt is made to forcibly fire the instrument while engaged in interlock after all the clips has been fired, the lugs are designed to break as noted.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 II
• 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: 9606462
• MDR Text Key: 175650235
• Report Number: 9612501-2020-00110
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057869
• UDI-Public: 10884521057869
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J9L0842NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR