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

Model Number	TA6048S
Medical Device Problem Codes	Failure to Align (2522); Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during an open low anterior resection (lar), when the stapler was fired, it was noticed that the guide pin did not engage correctly and the staple line did not fully form.The staples were in some instances were not compressed and still in the "goalpost" shape.Unformed staples fell into the patient's cavity, and loose staples were initially retrieved using forceps.It was noted that all components were successfully retrieved.As a result, the anastomosis was failed and the incision was extended more than an inch.To resolve the issue, further resection of colon re anastomosis was performed.The surgical time was extended 30minutes or more due to the product problem.
Additional Manufacturer Narrative
Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted damage between the jaws of the instrument, consistent to application over an obstruction.Also, the loading unit displayed a full complement of staples and the interlock was engaged.It was reported that the staples did not form as expected, a component disassociated from the device into the surgical cavity, the retaining pin did not seat properly upon the first squeeze of the handle, and staples were missing from the staple line after firing.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the device is applied over an obstruction damaging the pushers.Also, when the sulu is loaded with the pin slide and thumb buttons advanced.The current packaging design prevents proper sealing with the sulu improperly loaded, indicating the sulu was improperly loaded after receipt by the user.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: the ta must not be used in instances where the retaining pin cannot be positioned securely in the retaining pin hole in the anvil jaw.Failure to secure the retaining pin may result in improperly formed staples and a compromised staple line, and may cause bleeding, leakage, or disruption.To reload the instrument, grasp the new, unused loading unit by the finger pads, with the staple holes facing the instrument anvil.Insert the loading unit into the metal cartridge housing and push firmly downward until the single use loading unit clicks into position.The instrument jaws will not close if a sulu is not loaded in the jaws, if the sulu is not fully loaded into the jaws, or if a fired, or partially fired, sulu is in the jaw.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: TA
• 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: 17765527
• Report Number: 2647580-2023-04034
• Device Sequence Number: 6664280
• Product Code: GDW
• UDI-Device Identifier: 10884521043237
• UDI-Public: 10884521043237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: TA6048S
• Device Catalogue Number: TA6048S
• Device Lot Number: P0B1106MNY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• 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
• Patient Sex: Unknown