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

Model Number EGIA45AMT

Device Problems Break (1069); Component or Accessory Incompatibility (2897)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

According to the reporter, prior to a procedure, when the adapter was attached to the handle, the adapter yellow swim lane error was displayed in the handle screen.The reload was tried to be connected to the adapter, but it was unable to be connected physically, reload did not attach properly to the tip of the adapter, reload release button did not return to the initial position and it was in a state where the red part was visible on the blue tab.Another adapter and cartridge were used to resolve the issue.There was no patient involvement.Medtronic's initial evaluation of the incident is that the investigation detected an unreported condition of reload thick tissue and knife blade damaged that has no relationship to the reported condition.

Manufacturer Narrative

D10 concomitant product: sigadaptstnd - sig power sigadaptstnd linear adapter, serial# (b)(6) sigphandle - sig power sigphandle handle, sigpshell - sig power sigpshell control shell, 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

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was fully fired and the interlock was engaged.The jaw of the reload was open.Three staples remained on the cartridge surface were properly formed.Functionally, the reload was loaded into a representative pmv handle.The reload was loaded with the handle repeatedly and no functional abnormalities were found.The interlock was overridden and the reload was applied to test media.Test media was transected and  the reload interlock was tested and found to function properly.It was reported that the adapter was difficult to load.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: reload thick tissue and reload knife blade damaged.Visual inspection noted there were deformed anti-friction nylon pads on i-beam, staple pushers were partially pushed back to the cartridge.Damage to the cutting edge of the knife blade was observed.The knife channel had damage to the cutting edge of the knife blade.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: failure to completely fire the reload will result in an incomplete cut and incomplete staple formation, which may result in poor hemostasis and leakage.Always inspect the tissue thickness and select an appropriate staple size prior to application of the device.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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): 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: 18370339
• MDR Text Key: 331052050
• Report Number: 2647580-2023-05484
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003154
• UDI-Public: 10884523003154
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/03/2024

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: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Device Lot Number: P3A0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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