MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGMRET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open thoracotomy for middle and lower lobe pulmonary resection, while at the thoracotomy lung middle and lower lobectomy, the instruments were tried to be used for resection, but the excessive force mark appeared immediately after the firing.The firing was advanced, but the clamp cover stopped at the line at the graduation 5, they tried to release it, but it did not return.The staple line was incomplete at the distal.They pressed and held the green button on both sides to restart, but the knife did not return.The handle was removed from the adapter with the powered approach and re-attached, but it did not return.The manual adapter tool was taken out and an attempt was made to release it, but it was hard and did not move to the right.Another adapter and cartridge were taken at the discretion of the surgeon, connected with the same handle, and an additional resection was performed by stapling the surrounding tissue to resolve the unanticipated tissue loss and a permanent tissue damage.A part of it was dissected with another device, and they clamped the tissue together with the cartridge, which did not operate, then removed it to the surgical field.Seven staplers were used to perform vessel and pulmonary parenchyma without any problems.However, when the other reload was attached and the firing and resection were performed at the middle and lower lobe bronchial resection, the stapling was completed to the end, but it did not return to the original position, so the event recurred.The person in charge re-entered the room and tried restarting/powered approach, but it did not return.Returning it with the manual adapter tool was tried, but it was hard and did not move.Even so, the adapter tool turned it using the same method, but the root of the adapter tool got damaged.As the bronchial tissue had been completed to cut, the jaws were forcibly opened a little with forceps, and removed from the tissue of patient, then the device was removed to the surgical field.Since then, the surgery was completed by using another reload, handle, adapter and manual retract tool.When the sales representative checked with the surgeon later, the surgeon said, a big strange sound of click was heard at the beginning of the firing and at the completion of the firing when the second problem occurred.The surgical time was extended 30 minutes or more.
Event or Problem Description
According to the reporter, during an open thoracotomy for middle and lower lobe pulmonary resection, while at the thoracotomy lung middle and lower lobectomy, the instruments were tried to be used for resection, but the excessive force mark appeared immediately after the firing.The firing was advanced, but the clamp cover stopped at the line at the graduation 5, they tried to release it, but it did not return.The staple line was incomplete at the distal.They pressed and held the green button on both sides to restart, but the knife did not return.The handle was removed from the adapter with the powered approach and re-attached, but it did not return.The manual adapter tool was taken out and an attempt was made to release it, but it was hard and did not move to the right.Another adapter and cartridge were taken at the discretion of the surgeon, connected with the same handle, and an additional resection was performed by stapling the surrounding tissue to resolve the unanticipated tissue loss and a permanent tissue damage.A part of it was dissected with another device, and they clamped the tissue together with the cartridge, which did not operate, then removed it to the surgical field.Seven staplers were used to perform vessel and pulmonary parenchyma without any problems.However, when the other reload was attached and the firing and resection were performed at the middle and lower lobe bronchial resection, the stapling was completed to the end, but it did not return to the original position, so the event recurred.Even so, the adapter tool turned it using the same method, but the root of the adapter tool got damaged.As the bronchial tissue had been completed to cut, the jaws were forcibly opened a little with forceps, and removed from the tissue of patient, then the device was removed to the surgical field.Since then, the surgery was completed by using another reload, handle, adapter and manual retract tool.The surgeon later on said that, there was a big strange sound heard of click at the beginning of the firing and at the completion of the firing when the second problem occurred.The surgical time was extended 30 minutes or more.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was damaged due to applying excessive torque to a manual retract tool.It was reported that the device broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15013876
• Report Number: 1219930-2022-02662
• Device Sequence Number: 11342112
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: 10884521543881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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 Model Number: SIGMRET
• Device Catalogue Number: SIGMRET
• Device Lot Number: C7E7402X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown