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

Model Number 133650

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during an open gastrectomy procedure, while the vessels was ligated, the clips on two devices got stuck on the jaw and could not be applied.The surgeon was unable to squeeze the handle.The device was replaced to complete the case and resolve the issue.There was no patient injury.

Manufacturer Narrative

Additional information: b5, 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 device was received disassembled.It was reported that the clips did not load properly into the jaws as expected, and the safety interlock deployed prior to all staples or clips firing.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Separated body condition may occur either when applying leverage to the handles forcing the body tab to separate and or leverage is applied to the distal end of the unit causing the tabs to separate.In addition, this will prevent the instrument from functioning properly.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.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.

Event Description

According to the reporter, during an open gastrectomy procedure, while the vessels were ligated, the clips on three devices got stuck on the jaw and could not be applied.The surgeon was unable to squeeze the handle.The device was replaced to complete the case and resolve the issue.There was no patient injury.

• Brand Name: PREMIUM SURGICLIP III
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13289038
• MDR Text Key: 284011834
• Report Number: 2647580-2022-00192
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: 10884521517394
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K142869
• 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: 04/19/2022

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: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P0M2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2020
• 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