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

Model Number EGIAUSTND

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

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic procedure, after opening the device, the stapler was broken, and it did not accept another reload.There was no patient injury.

Manufacturer Narrative

D10 concomitant product: unknown egia su, unknown endo gia sulu (lot#unknown) 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 instrument firing knobs were retracted.The articulation lever was in neutral position.A hole in the shaft was visible.The cover tube appeared misaligned.Functionally, a representative reload was unable to be loaded into the instrument.Engineering observed the instrument outer tube at the area where it contacts the body and loads to reload sulu (single use loading unit) was observed rotated or torn suggesting potential difficulty during unloading.An obstruction was observed inside the distal end of the tube impeding the loading of any single loading unit.When instrument was manually managed to remove the obstruction, it was able to function as expected for loading/unloading, clamp/unclamp and cycling with a dummy sulu.The object removed was identified as a fragment coming from a reload (sulu) described as the locking tab that connects to the instrument for loading and locking in place.It was reported that the stapler was broken, and it did not accept another reload.The reported issue was confirmed.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: ensure that the load alignment indicator on the reload aligns with the load alignment indicator on the shaft.Push the reload in and twist clockwise 45° relative to the instrument, so that the reload will lock into place and an audible click is heard.When the reload is loaded properly into the stapler the blue unload button underneath the shaft is seated in place without showing any red coloration underneath.Unloading section 3 instructs to ensure that the jaws of the reload are open by pulling the black return knob back completely.Pull the light blue unload button (g) (located on the underside of the shaft near the loop handle) back towards the instrument, twist the reload counterclockwise 45° and remove the reload from the shaft of the instrument.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDO GIA ULTRA
• 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: 18673120
• MDR Text Key: 335205443
• Report Number: 2647580-2024-00710
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884523003540
• UDI-Public: 10884523003543
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P3K1274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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