MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG30AV
Medical Device Problem Codes	Entrapment of Device (1212); Misfire (2532)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a thoraco/esophagus procedure, when clamping the azygos venous arch, the green button remained pooped out and the handle was not pushed out ether.When opening and closing the handle for several times, the handle was pushed out and it became possible to fire.Even though the device was fired, it could not fire for more than 1 scale.Cutting was performed after performing ligation and clipping on the two sides.Surgeon used another handle and the problem was resolved.The surgical time was extended by more than 30 min.Additional tissue resection was required due to the issue.The device was removed from the tissue by additionally resecting the tissue.It was also noted that the device was removed from the tissue by additionally resecting the tissue.
Event or Problem Description
According to the reporter, during a thoraco/esophagus procedure, when clamping the azygos venous arch, the green button remained pooped out and the handle was not pushed out ether.When opening and closing the handle for several times, the handle was pushed out and it became possible to fire.Even though the device was fired, it could not fire for more than 1 scale.Cutting was performed after performing ligation and clipping on the two sides.Surgeon used another handle and the problem was resolved.The surgical time was extended by more than 30 min.The tissue was freed from the device by pulling back the black knob.No patient injury.
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.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted that the reload was pre-fired and engaged in interlock with the jaws open.Functional testing of the reload found no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the pre-fire condition with interlock engagement may occur if the instrument firing handle had been partially compressed and released after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time by ceasing the placement of staples and tissue transection and prevent patient harm.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9111337
• Report Number: 1219930-2019-05362
• Device Sequence Number: 13949367
• Product Code: GDW
• UDI-Device Identifier: 10884521543676
• UDI-Public: 10884521543676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2019

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: 10/31/2023
• Device Model Number: SIG30AV
• Device Catalogue Number: SIG30AV
• Device Lot Number: N8L0785Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 12/11/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/25/2019; 12/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR