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

Model Number E4055-CT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2022

Event Type  Injury  

Manufacturer Narrative

Title: radiofrequency outcomes of coblation tonsillectomy versus bipolar electrocautery tonsillectomy in pediatric population source: eltelety et al.| the egyptian journal of otolaryngology (2022) 38:152 | published online 26 november 2022 | https://doi.Org/10.1186 /s43163-022-00340-9.Ahmad m.Eltelety, mohamed e.Swelam, hazem m.Dewidar and ahmed m.El batawi.D10 concomitant product: forcefx, forcefx discon use forcfx-8.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.

Event Description

According to the literature, a prospective study aimed to compare the outcomes after bipolar electrocautery tonsillectomy versus coblation tonsillectomy in pediatric patients, age 3-12, between february and august 2022.A total of 120 patients were randomly divided into two equal groups.Sixty patients underwent coblation tonsillectomy with a competitor device and sixty patients underwent bipolar electrocautery tonsillectomy using force fx with straight bipolar forceps with the device set at 40 for both dissection and cauterization.All patients had the procedure done under general anesthesia and oral endotracheal intubation.Acetaminophen and ibuprofen were used for pain control and antibiotics were given in.On the last visit, the overall pain scale was scored over 40 represented the worst pain scale (the total number of 4 visits).Six patients in the bipolar group experienced postoperative bleeding or hemorrhage.Two patients bled after 24 h (reactionary), two after 48 h (reactionary), one after 4 days (secondary), and one after 1 week (secondary).All of them were admitted to the hospital, and the bleeding was controlled by conservative methods.None of them needed reoperation.

Event Description

According to the literature, a prospective study aimed to compare the outcomes after bipolar electrocautery tonsillectomy versus collation tonsillectomy in pediatric patients, age 3-12, between february and august 2022.A total of 120 patients were randomly divided into two equal groups.Sixty patients underwent collation tonsillectomy with a competitor device and sixty patients underwent bipolar electrocautery tonsillectomy using force fx with straight bipolar forceps with the device set at 40 for both dissection and cauterization.All patients had the procedure done under general anesthesia and oral endotracheal intubation.Acetaminophen and ibuprofen were used for pain control.On the last visit, the overall pain scale was scored over 40 represented the worst pain scale (the total number of 4 visits).Six patients in the bipolar group experienced postoperative bleeding or hemorrhage.Two patients bled after 24 h (reactionary), two after 48 h (reactionary), one after 4 days (secondary), and one after 1 week (secondary).All of them were admitted to the hospital, and the bleeding was controlled by conservative methods.None of them needed reoperation.

Manufacturer Narrative

Correction: b5.Additional information: g3.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

Additional information: b5, g3, h6 (fdd) new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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.

Event Description

According to the literature, a prospective study aimed to compare the outcomes after bipolar electrocautery tonsillectomy versus coblation tonsillectomy in pediatric patients, age 3-12, between february and august 2022.A total of 120 patients were randomly divided into two equal groups.Sixty patients underwent coblation tonsillectomy with a competitor device and sixty patients underwent bipolar electrocautery tonsillectomy using force fx with straight bipolar forceps with the device set at 40 for both dissection and cauterization.All patients had the procedure done under general anesthesia and oral endotracheal intubation.Acetaminophen and ibuprofen were used for pain control.On the last visit, the overall pain scale was scored over 40 represented the worst pain scale (the total number of 4 visits).Six patients in the bipolar group experienced postoperative bleeding or hemorrhage of less than 50 ml.Two patients bled after 24 h (reactionary), two after 48 h (reactionary), one after 4 days (secondary), and one after 1 week (secondary).All of them were admitted to the hospital, and the bleeding was controlled by conservative methods.None of them needed reoperation.The bleeding events were not directly related to a device as there were no device issues.

• Brand Name: VALLEYLAB
• 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: 17346029
• MDR Text Key: 319382469
• Report Number: 1717344-2023-00875
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524000787
• UDI-Public: 10884524000787
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: E4055-CT
• Device Catalogue Number: E4055-CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 08/12/2023
• Supplement Dates FDA Received: 08/16/2023; 09/06/2023
• 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: PLEASE SEE NOTE ON H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 6 YR