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

Model Number	SIGMRET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Breakdown (2681); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel (lot#:n4c2164y), sigphandle, sig power sigphandle handle (serial#:(b)(6)), sigadaptstnd, sig power sigadaptstnd linear adapter (serial#:(b)(6)).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.
Event or Problem Description
According to the reporter, during a vertical gastrectomy, when using the second reload, after firing, when trying to retract the scalpel, it did not retract, the device locked onto tissue.Then, an attempt was made to disconnect the power handle from the adapter and reconnect it, but nothing happened.The power handle was restarted with the same result.Finally, it was tried with a retraction key.The retraction key broke, and a second key was used.The reload was advanced to the end again.A click was heard, and then it was retracted with the retraction key.A manual retraction wrench was used.Finally, the scalpel was retracted without any apparent damage in the reloading or in the staples.The surgical time was extended by 20 minutes due to device issue.
Additional Manufacturer Narrative
Additional information: g3 correction: b5, h6.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.
Event or Problem Description
According to the reporter, during a vertical gastrectomy, when using the second reload, after firing, when trying to retract the scalpel, it did not retract, the device locked onto tissue.Then, an attempt was made to disconnect the power handle from the adapter and reconnect it, but nothing happened.The power handle was restarted with the same result.Finally, it was tried with a retraction key.The retraction key broke, and a second key was used.The reload was advanced to the end again.A click was heard, and then it was retracted with the retraction key.A manual retraction wrench was used.Finally, the scalpel was retracted without any apparent damage in the reloading or in the staples.The surgical time was extended by 20 minutes due to device issue.There was no patient injury.

• 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: 19636115
• Report Number: 1219930-2024-02940
• Device Sequence Number: 7400263
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: 10884521543881
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: SIGMRET
• Device Catalogue Number: SIGMRET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown