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	Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sigadaptstnd - sig power sigadaptstnd linear adapter, serial# (b)(6) sigadaptstnd - sig power sigadaptstnd linear adapter, serial# (b)(6) sigtrsb60amt - sigtrsb60amt 60mm med thk reinforced rel, lot# unknown sigmret - sig power sigmret manual retract tool, lot# c7f7401x sigphandle - sig power sigphandle handle, serial# unknown sigpshell - sig power sigpshell control shell, lot# unknown sigphandle - sig power sigphandle handle, serial# unknown sigadaptstnd - sig power sigadaptstnd linear adapter, serial# unknown 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.
Event or Problem Description
According to the reporter, during a laparoscopic pancreatectomy surgery with robot support, at the time of pancreas resection, the knife advanced with the feeling that it was pushed a little, then stopped, then pushed and then stopped, and so on as the knife forward (not as much as tapping).At that time, even though the firing button was not pressed, the knife suddenly advanced and fired till the end.Afterwards, the device could not be released even when the button was pressed and displayed a yellow exclamation mark above the adapter swimlane.The adapter was removed and reattached, but the device was still not released.A new handle and shell were used, but the issue remained the same.The surgeon then tried releasing the device using two manual adapter tools, but it was so hard and did not turn and the adapter tools were damaged.A new adapter was attached to the device, but the device could still not be released and an adapter swimlane error was displayed.As a result, a scalpel, a generator, and a ligasure devices were used, and the pancreas was resected on the central side from the originally intended resection line.This led to about 30 minutes extended surgical time, less than 1 inch extended incision, and tissue defect.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the manual retract tool was broken.It was reported that the instrument broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if excessive torque is applied to the manual retract tool 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 55112 ; 7635265677
• MDR Report Key: 18406601
• Report Number: 1219930-2023-05389
• Device Sequence Number: 16817195
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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
• Device Lot Number: C7F7401X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Unknown