MAUDE Adverse Event Report: CELESTICA DE MONTERREY S.A. DE C.V. ENDO GIA; STAPLE, IMPLANTABLE

Model Number 030458

Device Problems Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

According to the reporter, during the laparoscopic complete stomach resection for cancer, while on anastomosis, there was incorrect b staple formation in all 12 reloads that were used; some were not properly formed, and some staples were opened.This causes the patient to have tissue bleeding and even spill bowel contents into the abdominal cavity.The staple line was incomplete distally and had to be reinforced with a suture to fix the staple line and resolve the issue.It was noted that the staples that fell off in the cavity and that were left open were removed.

Manufacturer Narrative

D10 concomitant products: 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) ; 030458, 030458 endo gia r/or 60 3.5mm (lot#:t2b123x) 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 GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer (Section G): CELESTICA DE MONTERREY S.A. DE C.V.; calle octava #102; parque industrial monterrey; apodaca nuevo leon ; MX
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18804038
• MDR Text Key: 337562710
• Report Number: 3003139373-2024-00051
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 030458
• Device Catalogue Number: 030458
• Device Lot Number: T2B123X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2024
• Date Device Manufactured: 02/26/2022
• 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 H11