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

Model Number	SIGSDS30CTV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a thoracoscopically assisted right upper lobectomy, during firing at the interlobar pulmonary artery, the cartridge section shakes slightly to the left and right about five times.After firing, there was a staple line bleeding from the blood vessel stump.The surgeon applied pressure hemostasis for arterial bleeding and use a hemostatic agent to stop the bleeding.Bleeding was observed again in the same site when the lymph node was resected, so a hemostasis treatment was performed again.There was a tissue damaged and surgical time was extended by more than 30 minutes.
Additional Manufacturer Narrative
Concomitant products: sigphandle, sig power sigphandle handle (sn# (b)(6)) sigpshell, sig power sigpshell control shell (lot# unknown) sigadaptstnd, sig power sigadaptstnd linear adapter (sn# 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted that one reload was inside of a tissue cavity.A staple line was visible in the returned video.The reload was clamped onto a small piece of tissue.The i beam and sled were advanced to the distal end of the staple cartridge.The i beam was retracted.As the reload jaws were open, blood began to pour from the transected tissue.Several loose staples could be seen in the tissue cavity.Blood pooled in the tissue cavity.It was reported that staple line was bleeding.The reported issue was 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 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: 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 55112 ; 7635265677
• MDR Report Key: 19529141
• Report Number: 1219930-2024-02633
• Device Sequence Number: 7549803
• Product Code: GDW
• UDI-Device Identifier: 10884521741874
• UDI-Public: 10884521741874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191070
• 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
• Report Date (Section B): 08/22/2024

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: SIGSDS30CTV
• Device Catalogue Number: SIGSDS30CTV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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