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

Model Number	SIG60CTAMT
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle (serial# unknown) sigpshell, sig power sigpshell control shell (lot# unknown) sigadaptstnd, sig power sigadaptstnd linear adapter (serial# unknown) sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12mm (lot# 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy revision, on stomach stapling, the first load used was unable to fire.The second and third loads fired fine.The fourth load experienced a partial firing.After the partial firing there was a loose staple seen in the patient's abdominal cavity.Either from the stapler cartridge or a previous firing.It was noted that the surgical time was extended by 45 minutes.The physician requested use of a different device and that was used to complete the procedure.
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy revision, on stomach stapling, the first load used was unable to fire.The second and third loads fired fine.The fourth load experienced a partial firing.After the partial firing there was a loose staple seen in the patient's abdominal cavity.Either from the stapler cartridge or a previous firing.The user removed the staples using a laparoscopic grasper.It was noted that the surgical time was extended by 45 minutes.The physician requested use of a different device and that was used to complete the procedure.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction reportable.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: TRI-STAPLE 2.0
• 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: 20207441
• Report Number: 1219930-2024-04228
• Device Sequence Number: 12466304
• Product Code: GDW
• UDI-Device Identifier: 10884521543683
• UDI-Public: 10884521543683
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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 Model Number: SIG60CTAMT
• Device Catalogue Number: SIG60CTAMT
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• 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 H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown