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

Model Number TRIEEA28MT

Device Problems Difficult to Remove (1528); Failure to Form Staple (2579); Failure to Cut (2587)

Patient Problems Failure to Anastomose (1028); Tissue Breakdown (2681)

Event Date 03/19/2024

Event Type  Injury  

Event Description

According to the reporter, following a procedure for a sigmoid volvulus wherein a 25mm circular stapler was used, the patient developed bleeding from staple line and required an emergent return to the operating room for bleeding control and was then left in discontinuity due to instability.The patient was then brought back to the operating room for a third procedure wherein the recent laparotomy was reopened to resect the bleeding prior to a rectosigmoid anastomosis to restore the bowel continuity.During the procedure, the 28mm device partially fired.The surgeon opened the stapler as the donuts had not been fully transected and where still attached to the bowl in one area; and then separated the anvil from the distal stapler handle so it could be removed from the rectum.Afterwards, the surgeon transected the donuts from the anastomosis which was only approximately 25% intact and then separated the partial anastomosis.A contour stapler was then used to reclose the distal rectal stump.After reassessing if there was length to perform t he anastomosis again, the surgeon used a new circular device to resect approximately 2cm on the distal stump.Due to previous issues and multiple surgeries, the surgeon elected to protect that anastomosis with a loop ileostomy.It was noted that the patient had a bad tissue which was friable related to being a redo from the initial staple line/anastomosis bleeding.

Manufacturer Narrative

D10 concomitant product: eea25, eea25 eea 25mm sgl use stapler, (lot #unknown).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 Description

According to the reporter.Following a procedure, for a sigmoid volvulus.Wherein a 25mm circular stapler was used.The patient developed a concerning amount of bleeding from staple line.Which required multiple blood transfusions.And an emergent return to the operating room for bleeding control.And was then left in discontinuity, due to instability.The patient was then, brought back to the operating room for a third procedure, wherein the recent laparotomy was reopened to resect the bleeding, prior to a rectosigmoid anastomosis to restore the bowel continuity.During the procedure, the 28mm device partially fired.The surgeon opened the stapler, as the donuts had not been fully transected.And where still attached to the bowl in one area.And then separated, the anvil from the distal stapler handle, so it could be removed from the rectum.Afterwards, the surgeon transected the donuts, from the anastomosis.Which was only approximately 25% intact and then separated the partial anastomosis.A contour stapler was then used to reclose the distal rectal stump.After reassessing if there was length to perform the anastomosis again.The surgeon used a new circular device to resect approximately 2cm on the distal stump.Due to previous issues and multiple surgeries.The surgeon elected to protect that anastomosis with a loop ileostomy.It was noted, that the patient had a bad tissue.Which was friable related to being a redo from the initial staple line/anastomosis bleeding.Following the third procedure, while in the icu, the patient developed another leakage from the staple line.Which, only required a drain to be placed, due to the temporary loop ileostomy created, during the third procedure.

Manufacturer Narrative

H6: (imf code: f0801).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
• Type of Device: 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: 19106235
• MDR Text Key: 340162656
• Report Number: 2647580-2024-01642
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884521593022
• UDI-Public: 10884521593022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRIEEA28MT
• Device Catalogue Number: TRIEEA28MT
• Device Lot Number: P2G0505Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2022
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 80 KG