MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCD7A39

Device Problems Self-Activation or Keying (1557); Difficult or Delayed Activation (2577); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

According to the reporter, during implementing of laparoscopic colectomy, when the mesentery was being dealt with sonicision7, even though the minimum mode button was not pressed, an output sound rang and the led indicator light flashed red and blue along with an error sound.Once the dissector was removed externally from the trocar, and while the tip was being cleaned, it returned to its usual green light and it was able to be used again.When the trocar was inserted into the body once again and the output button was pressed, the minimum mode continued to be outputted even though the surgeon has released his finger from the output button, and an error sound rang and the led indicator flashed red and blue along with an error sound.Once again to attempt restart, it was reconnected by scrub nurse but the led indicator flashed red and blue along with an error sound, making it unusable.Both the dissector and generator were certainly sonicision7 products, and were able to be used for 3 hours after the surgery started.When the defective gener ator, which had become non-sterile was connected, to the dissector of sonicision7 26cm demo machine, the led indicator flashed red and blue, resulting in the same defective behavior.Afterwards, when another generator was connected to the same 26 cm dissector, it started up as usual.When the 39 cm dissector, which had also become non-sterile as a defective product was examined, it was found that the output button was probably broken, and it was always in minimum mode, making it impossible to press it to second level.There was no patient injury.

Manufacturer Narrative

D10: concomitant product: scg7ab, sonicision 7 generator b scg7ab, (sn: (b)(6)).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: a2, a3a, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted a piece of particulate matter under the activation button.Functional testing found that the torque adaptor had melted.The r emnants of the torque adaptor were scattered in the handle body.A larger piece became wedged under the activation button and interfered with its proper function.It was reported that the device was activating intermittently and self activating.Also, the unit switch, knob and button failed.The reported issues were confirmed.The most likely cause was traced to a component failure.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: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 18842569
• MDR Text Key: 337106855
• Report Number: 1717344-2024-00620
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521794795
• UDI-Public: 10884521794795
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCD7A39
• Device Catalogue Number: SCD7A39
• Device Lot Number: 30260101X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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
• Treatment: SEE H11
• Patient Age: 77 YR
• Patient Sex: Male