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

Model Number UNKNOWN PENCIL

Device Problems Melted (1385); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: 06725, es generator 06725 ss501sx microp 400w (serial#: (b)(6)); e7510-25 polyhesive ii ped ret el x25 (lot#: 13140121x) 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 total ventricular atrio channel correction procedure, the disposable plate was glued to the back (dorsal region) of the patient.However, the burn was on the patient's leg.As shown on the photo report, the patient received 2nd degree burn, bullous lesions on the left leg, on the shin, characteristic of a burn shown small bubbles.The cautery pen was also visible in the photo as damaged and melted insulation.The patient was discharged normally.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted the pencil was shown in the picture.Without receiving the device, a detail investigation could not be performed for the reported complaint.It was reported that the device was related to burn.The reported issue could not be confirmed.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during a total ventricular atrio channel correction procedure, the disposable plate was glued to the back (dorsal region) of the patient.However, the burn was on the patient's leg.As shown on the photo report, the patient received 2nd degree burn, bullous lesions on the left leg, on the shin, characteristic of a burn shown small bubbles.It was unknown whether the rem pad or handpiece caused the burn on the leg because the surgery is cardiac, and the accessories were used on the chest area and not on the leg.The cautery pen was also visible in the photo as damaged and melted insulation.It was confirmed from the follow-up that the cautery pen used was non-medtronic device.The patient was discharged normally.

Manufacturer Narrative

Additional information: b5, g3, h6 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: UNKNOWN PENCIL
• 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: 18909034
• MDR Text Key: 337750192
• Report Number: 1717344-2024-00710
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: UNKNOWN PENCIL
• Device Catalogue Number: UNKNOWN PENCIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/26/2024
• Supplement Dates FDA Received: 03/25/2024; 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 7 KG