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

Model Number SIGADAPTXL

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Retraction Problem (1536); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 03/31/2023

Event Type  Injury  

Event Description

According to the reporter, on laparoscopic vertical sleeve gastrectomy, during the first firing for sleeve creation, the doctor was unable to get the stapler in the right position as the patient was tight due to tummy tuck and tight falciform ligament.The surgeon used the reload to create some space, leveraging the stapler.At the time, the connecting joint of the reload and adapter was outside of the trocar.While the surgeon was creating the space with the reload, there was a slight snapping noise.The whole stapler was checked.The stapler screen was all green swim lane and was deemed normal.The first 60mm purple reload was then fired.The knife advanced all the way but then would not retract.Troubleshooting was performed and it was noticed that the connection joint at the reload and adapter had become loose.The manual retraction tool was tried but did not work.A new adapter was tried on but still would not work.This time, the adapter was stuck but was needed to be taken off the seal of the port as the competitor's trocar was removed to create more room to try and remove the reload.The surgeon broke the adapter off.The surgeon tried to use a right angle to physically drag the i-beam backward, but the device would not budge.The sales representative had consulted with the member service representative and the device hotline, but the issue could be resolved.The surgeon decided to cut the reload out of the stomach with mini shears.The stomach started bleeding, then the surgeon used a sealing device to seal the major vessels that were squirting blood.The surgeon then sutured the stomach to close it just enough to re-staple.A new set of handle, power shell, adapter, and reload were used to finish the sleeve.The sleeve was completed by starting the staple line just distal to the cut line created by removing the reload with mini shears.The procedure was extended for almost two hours due to the issue.The incision extended by not more than 1 inch (2.54cm).

Manufacturer Narrative

D10 concomitant product/s: sigadaptxl sig power sigadaptxl linear xl adapter serial #:(b)(4) sigphandle sig power sigphandle handle serial #:(b)(4) sigtrsb60amt sigtrsb60amt 60mm med thk reinforced rel lot #:unknown sigpshell sig power sigpshell control shell lot #: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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unload switch was at the home position and there was slight damage to the underside of the adapter firing rod hooks.Functionally, the unload switch was depressed multiple times and showed no hang-ups or sluggishness.The adapter was then connected to the gen2 adapter black box running gen2 acc software and the strain gauge was responsive.The adapter had 35 of 50 procedures remaining.There was an articulation calibration error present in the data saved to the adapter.The adapter was connected to a representative handle running v29.5 software and the device calibrated correctly.A representative reload was attached to the adapter and was able to be loaded and unloaded without difficulty.The unit was able to be rotated and articulated in all directions without hang-ups or sluggishness.The unit was able to be fired without any issues.After firing, the unit was reconnected to the gen2 acc software and no new errors appeared.It was reported that there was difficulty retracting the knife blade, difficult to remove instrument from the trocar, difficult to unload and instrument locked on tissue.The reported issues were confirmed.The most likely cause was not be traced to device.It was also reported that there was a damage to the firing rod.The reported issue was confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: there was an articulation calibration error.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 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
• Type of Device: 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: 16752379
• MDR Text Key: 313420834
• Report Number: 1219930-2023-01515
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543812
• UDI-Public: 10884521543812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention