MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number 134051

Device Problems Mechanical Problem (1384); Mechanics Altered (2984)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/19/2023

Event Type  malfunction  

Event Description

According to the reporter, during an open total thyroidectomy, none of the clips loaded properly into the jaws of the four devices.It was noted that the clips had been malformed.Additionally, the incision was extended due to the problem with the product.The issue was resolved by using sutures.

Manufacturer Narrative

D10 concomitant products: 133650, 133650 premium surgiclip iii 9.0, (lot #p3g0290).134051, 134051 premium surgiclip ii 9.75, (lot #p2c0656).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.

Manufacturer Narrative

Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was partially fired with three clips remaining in the channel.There was no clip loaded in the jaw, the ratchet function was engaged, the distal end of the channel cover was intact and the jaws appear to be co-planar.Functionally, the ratchet function was disengaged.The remaining clips were fired properly on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and return to the open position.Each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaws from approximating.The instrument was disassembled to reveal damage to the ratchet system.It was reported that none of the clips loaded properly into the jaws of the four devices and the clips had been malformed.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the firing stroke is not completed and the handles opened with the ratchet function on during use.It was also reported that the incision was extended due to the problem with the product.The reported issue could not be confirmed.The product analysis noted evidence that the device was not used as intended.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: ensure that the handles are squeezed together firmly as far as they will go.Failure to squeeze then handles completely can result in clip malformation and possible bleeding or leakage.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: PREMIUM SURGICLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18340510
• MDR Text Key: 331005414
• Report Number: 2647580-2023-05335
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057562
• UDI-Public: 10884521057562
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K143644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134051
• Device Catalogue Number: 134051
• Device Lot Number: P2C0656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Sex: Male