MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE EZ; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number FORCEEZ8CS

Device Problems Smoking (1585); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/27/2022

Event Type  Injury  

Event Description

According to the reporter, during a procedure, the otv staple removal the incision was made directly on the skin (without ioban type protective film) using a 23mm blade mounted on a size 4 scalpel handle.The surgeon took over the antero-external scar, using the electric scalpel with one hand and a dissecting forceps with the other.At the opening of the aponeurosis of the anterior leg muscle with the scalpel, the operating assistant had a very hot sensation in the hand and forearm, the claw became hot, so the assistant let go of it spontaneously and it fell to the ground.The surgeon stopped the use of the electric scalpel.The scalpel did not come into contact with the claw or the dissector, and a heat source started to rise like the hand in the oven according to the explanations given by the operating assistant.A smoke was then seen with no visible flame.The operating room nurse, alerted by the noise of the claw on the floor, the surgeon and the operating assistant present in the room immediately proceeded to stop the generator and to leave the room, at the same time, the surgeon immediately proceeded to flush the knee with sterile naci, the operating assistant changed his two pairs of gloves, and there was no damage to the gloves, however, the orthopedic sock was found to have warmed up slightly and two small holes had formed, so it was removed.The generator was isolated, placed in quarantine.The patient had a third degree burn on the left knee, which requires a consultation in lyon at the burns department.

Manufacturer Narrative

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 reporter, during a procedure, the otv (tibial valgization osteotomy) staple removal the incision was made directly on the skin (without ioban type protective film) using a 23mm blade mounted on a size 4 scalpel handle, the surgeon took over the antero-external scar, using the electric scalpel with one hand and a dissecting forceps with the other, at the opening of the aponeurosis of the anterior leg muscle with the scalpel, the operating assistant had a very hot sensation in the hand and forearm, the claw became hot, so the assistant let go of it spontaneously and it fell to the ground, the surgeon stopped the use of the electric scalpel, the scalpel did not come into contact with the claw or the dissector, a heat source started to rise like the hand in the oven according to the explanations given by the operating assistant, a smoke was then seen with no visible flame above the surgical site with significant heat at the level of the claw retractors that were held by the operating assistant, alerted by the noise of the claw on the floor, the operating room nurse, the surgeon, and the operating assistant present in the room immediately proceeded to stop the generator and to leave the room, at the same time, the surgeon immediately proceeded to flush the knee of the patient with sterile naci, the operating assistant changed his two pairs of gloves, there was no damage to the gloves, however, the orthopedic sock was found to have warmed up slightly and two small holes had formed, so it was removed, the generator was isolated and placed in quarantine, the accessories used were all competitor brand accessories.The patient had a third degree burn on the left knee with the size of 10 cm wide by 8 cm long, which required a consultation in lyon at the burns department.

Manufacturer Narrative

(mfr name, street 1, mfr city, country code and postal code), d4(model #, catalog #, expiration date, serial # and udi), pma / 510(k) #.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 that the top housing rear fins were moderately to severely bent.Functional testing noted that none of the accessories connected were observed to overheat, even when used to activate the generator.It was reported that there was an adverse event without an identified device or use problem.A potentially related device issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a value that is out of specification.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: FORCE EZ
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15854095
• MDR Text Key: 304209556
• Report Number: 1717344-2022-01444
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEEZ8CS
• Device Catalogue Number: FORCEEZ8CS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2010
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 87 KG