MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN GIA PREMIUM; APPARATUS, SUTURING, STOMACH AND INTESTINAL

Model Number 030470

Device Problems Misfire (2532); Mechanics Altered (2984)

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

Event Date 05/27/2020

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 an open hemicolectomy procedure, while being applied on the large intestine, the staples did not deploy on the proximal part of the staple line.Staples were fired into the tissue just on one side of the blade.The bowel needed to be sewn manually by the surgeons to resolve the issue and complete the case.The surgical time was extended for 10 more minutes.

Manufacturer Narrative

Additional information: b5, d2 (product code, common device name), d4 (model#, catalog#, serial#, udi#), d10, g4, g5 (pma/510(k)), h3, h6.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.

Event Description

According to the reporter, while performing truncation on the pylorus of the stomach during an open hemicolectomy procedure, after firing, the distal portion of the bowel remained open and the staples were fired only on the proximal part of the staple line.From the stomach side all of the staples were fired.The other side, the doudenum remained open on the whole line.There were no staples fired at all.The bowel needed to be sewn manually by the surgeons to resolve the issue and complete the case.The surgical time was extended for 10 more minutes.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the device initially fires, but failed to complete the firing cycle.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.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: GIA PREMIUM
• Type of Device: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven,ct PR 06473 4401
• MDR Report Key: 10148177
• MDR Text Key: 194944604
• Report Number: 2647580-2020-01817
• Device Sequence Number: 1
• Product Code: FHM
• Combination Product (y/n): N
• PMA/PMN Number: K801590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

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 Model Number: 030470
• Device Catalogue Number: 030470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 09/09/2020
• Supplement Dates FDA Received: 07/09/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention