MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLER, SURGICAL

Model Number	EEAXL25
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanics Altered (2984)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946); Ventricular Fibrillation (2130); Foreign Body In Patient (2687)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during the minimally invasive esophagectomy, the circular stapler did not seem to fire correctly.When trying to create the anastomosis between esophagus and stomach, the stapler did not seem to deploy any staples, only cut which had bad results for anastomosis.The surgeon had to convert the procedure from laparoscopic to open to go into abdomen to further mobilize, and then start the procedure again with a different circular stapler.The surgical time was extended for six hours.The patient was currently in intensive care unit due to ventricular fibrillation.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.Microscopic evaluation of the anvil buckets noted no staple markings.It was reported that the staple did not deploy.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the instrument is handled rough.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Event or Problem Description
According to the reporter, during the minimally invasive esophagectomy, the circular stapler did not seem to fire correctly.When trying to create the anastomosis between esophagus and stomach, the stapler did not seem to deploy any staples, only cut which had bad results for anastomosis.The surgeon had to convert the procedure from laparoscopic to open to go into abdomen to further mobilize, and then start the procedure again with a different circular stapler.The surgical time was extended for 6 hours.The patient was currently in intensive care unit due to ventricular fibrillation.It was noted that the stapler cartridge ring with staples was found on a scan of the patient.It seems that the stapler cartridge must have popped off the stapler while it was being placed intercostal and the surgeon was not aware of this.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Correction: h6 (f1906) additional information: g3.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.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the instrument with a disengaged staple guide noted proper weld marks on the shell head.Further inspection noted that the green bar was visible in the indicator window and the safety feature was not engaged.The pusher fingers appeared to be intact, and inspection under the microscope displayed staple divots to the knife blade.The first anvil of the instrument was observed to be not tilted and separated from the instrument.Further inspection of the anvil cutting ring showed no traces of knife impression, and the ring was received intact.The second orvil anvil of the instrument was observed to be tilted and separated from the instrument.Further inspection of the anvil cutting ring showed deep traces of knife impression, and the ring was received completely severed.Microscopic evaluation of the anvil buckets noted no staple markings.It was reported that the staples did not deploy and the compo nent disengaged.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the instrument is handled roughly.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: EEA
• Common Device Name: STAPLER, SURGICAL
• 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: 19638529
• Report Number: 2647580-2024-02846
• Device Sequence Number: 8572764
• Product Code: GAG
• UDI-Device Identifier: 10884523006056
• UDI-Public: 10884523006056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/15/2025

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: EEAXL25
• Device Catalogue Number: EEAXL25
• Device Lot Number: P1L1169R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 09/26/2024; 10/15/2024; 12/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/02/2024; 10/21/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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; Other
• Patient Sex: Unknown