MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number FORCETRIAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seroma (2069)

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

D10: concomitant product: unknown progrip - unknown progrip mesh product, lot# unknown unkabstack - unknown absorbatack, lot# unknown unknown-vloc - unknown vloc product, lot# unknown literature events: krzysztof j.Wikiel1,2 · daniel bollinger1.Paul m.Montero1.Teresa s.Jones1.Thomas n.Robinson1.Edward l.Jones1 stray energy injury during robotic versus laparoscopic inguinal hernia repair: a randomized controlled trial; krzysztof j.Wikiel, 2023, surgical endoscopy https://doi.Org/10.1007/s00464-023-10331-3 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 Description

According to the literature, a prospective randomized controlled trial evaluated the transfer of stray energy during laparoscopic vs.Robotic transabdominal preperitoneal (tapp) inguinal hernia repair between 2019 and 2022.It was noted that monopolar energy was delivered by a force triad.A monopolar scissor was used to deliver energy at 30w coagulation for all cases.At completion of the procedure, skin biopsies were taken from all the port sites.A picro-sirius red stain was utilized to identify thermal injury by a blinded pathologist.However, no clinical manifestations were noted.

• Brand Name: FORCETRIAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18005732
• MDR Text Key: 326523437
• Report Number: 1717344-2023-01330
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521062099
• UDI-Public: 20884521062099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCETRIAD
• Device Catalogue Number: FORCETRIAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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
• Treatment: SEE H10