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

Model Number	010901
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a laparoscopic donor nephrectomy, while separating the renal artery and renal vein, the tissue did not come off from the cartridge when the jaw was opened after firing; it did not come off when an attempt was made to remove it using forceps, the jaw of device was fixated to tissue. an additional separation was attempted using powered stapler from the planned resection position during renal vein separation, however, the already bitten device did not work out well due to interference. the staple that was left in the cartridge fork is not a clean b-type. to resolve the issue and complete the case, emergency transition from laparoscopic surgery to laparotomy was done and the incision was expanded wider than expected, exceeded 1 inch (2.54 cm), the blood vessel was sutured with a needle suture, then cut with a scalpel then collect the tissue and the cartridge, and the surgery time was extended by 30 minutes or more.
Additional Manufacturer Narrative
Concomitant product: 010911l - 010911l multifire endo ta* 30-2.5 dlu x6, lot# p0c1213my sigphandle - sig power sigphandle handle, 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.
Additional Manufacturer Narrative
Additional information: a3, g3 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.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the first photo depicts the instruments jaw.The second photo depicts a blue arrow pointing to a component on the instrument.The third photo depicts the anvil of the single use loading unit (sulu).The fourth photo depicts a area of the instrument.The fifth photo depicts the instrument and the sulu.The sixth photo depicts the bottom and side of the anvil.The seventh photo depicts malformed staples on the sulu.The eighth photo depicts a circle and arrow on the sulu.Also, the instrument body displayed no abnormalities.The jaw was open and the cartridge noted the sulu was fully applied.It was reported that as a result of product failure, the laparoscopic surgery was required to be converted to an open surgery.Also, the staples did not form as expected and the jaws of the device remain closed on tissue.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: MULTIFIRE ENDO 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: 15512657
• Report Number: 2647580-2022-03474
• Device Sequence Number: 5242329
• Product Code: GDW
• UDI-Device Identifier: 10884521047747
• UDI-Public: 10884521047747
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910192
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2023

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 Expiration Date: 07/31/2025
• Device Model Number: 010901
• Device Catalogue Number: 010901
• Device Lot Number: P0H0188Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 01/05/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/17/2022; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female