MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study evaluated the efficacy and safety of parenchymal transection by the vessel sealing device compared with the stapler technique in patients who underwent open elective hepatic resection between november 2011 and july 2014.There were a total of 138 patients: there are 69 patients in the stapler hepatectomy group.In the stapler group, universal staple with 60millimeter (mm) reload with 2.5mm staples were used for parenchymal division.Complications included: intraoperative bleeding averaging to 961ml, 24 bile leaks, 3 hemorrhage after hepatectomy, 25 abdominal fluid collection and 9 sepsis.Blood transfusions, reoperations, radiologic intervention and extended hospital stay were reported.Article: randomized clinical trial of stapler hepatectomy versus ligasure¿ transection in elective hepatic resection author: j.Fritzmann year:2018 publication: john wiley <(>&<)> sons ltd.
Additional Manufacturer Narrative
Concomitant product/s: unknown ligasur unknown ligasure instrument lot #:unknown; unknown ligasur unknown ligasure instrument lot #:unknown; unknown ligasur unknown ligasure instrument lot #:unknown; 030454 030454 endo gia r/or 45 2.5mm lot #:unk; 030412 030412 endo gia uni 60 2.5 dlu x6 lot #:unk; 030412 030412 endo gia uni 60 2.5 dlu x6 lot #:unk; unknown endo gi unknown endo gia instrument lot #:unk (b)(4).Title: randomized clinical trial of stapler hepatectomy versus ligasure¿ transection in elective hepatic resection source: bjs 2018; 105: 1119¿1127 accepted: 4 may 2018.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
• Common Device Name: STAPLE, 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: 15825147
• Report Number: 2647580-2022-04229
• Device Sequence Number: 17628062
• Product Code: GDW
• UDI-Device Identifier: 10884523002911
• UDI-Public: 10884523002911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 030412
• Device Catalogue Number: 030412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male