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

Model Number 176657

Device Problem Mechanics Altered (2984)

Patient Problems Tissue Damage (2104); Injury (2348); No Code Available (3191)

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, when closing the cystic duct, when the grips were squeezed, no clips attached to the jaw and the jaw was compressed.There was an unanticipated tissue loss and tissue damage as a result of the problem.The surgical time was extended by thirty minutes or more due to injury.There a was patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with four remaining clips.Visual inspection noted that the collar under the shaft cover was bent.The jaws were misaligned.The shrink wrap was damaged.The distal shaft was bent.The condition of the instrument precludes functional evaluation.Note; the information for use states that if firing a clip over another clip or other obstructions may result in bleeding and/or leakage and may damage the instrument jaws.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of this condition may occur if the instrument is applied over an obstruction causing the jaws to misalign and damaging the component allowing the clips to eject from the device jaws unformed or malformed.Replication of the reported condition may occur when interaction between the instrument shaft and trocar system may result in a tear of the shrink wrap during device insertion or removal.Additionally, please be sure to avoid shrink wrap contact with sharps or cautery devices during the application.Replication of the damaged shaft condition may occur with intentional over flexure of the shaft during clinical application causing the shaft to bend or break.The root cause of the observed damage was misuse of the product 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 18750 ; DO 18750
• MDR Report Key: 8479857
• MDR Text Key: 140813836
• Report Number: 9612501-2019-00701
• Device Sequence Number: 1
• Product Code: FZP
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: J8A0861CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention