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

Model Number 176657

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, five units of clip appliers had an unknown issue.Surgical intervention was done to resolve the issue.There was tissue damage as a result of the event.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, five units of clip appliers would not provide adequate occlusion.The clips were crossed and malformed.Surgical intervention was done to resolve the issue.The surgical time was extended for more than 30 minutes.There was tissue damage as a result of the event.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the handle was broken and out position, in a manner consistent of cycling through the safety interlock.It was reported that the clips did not close completely and were malformed.The reported issue was confirmed.The most likely cause was traced to the user.This issue 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 manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the clip is positioned within the jaws and is free of other clips or obstructions before squeezing the handle to 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.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: 10626055
• MDR Text Key: 209758783
• Report Number: 9612501-2020-01416
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057845
• UDI-Public: 10884521057845
• Combination Product (y/n): N
• PMA/PMN Number: K143644
• 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: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: J0B2736NY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention