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

Model Number SCDA39

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 06/26/2023

Event Type  malfunction  

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 the procedure, when the device was being used again, the output button was pressed for confirmation outside the body.The finger was released from output button, but the button remained in pressed state and the output continued.The button was damaged.After that, the output became intermittent (the active blade did not come in contact with anything).After replacing the dissector, the new device was used without any problems.There was no patient injury.

Manufacturer Narrative

Product analysis #(b)(4):this report is based on information provided by post market vigilance (pmv) investigation personnel.Pmv received one scda39 for evaluation.The sample did meet specification as received.Visual inspection: the visual inspection found no notable conditions.Evaluation: - the device was tested using a test lab battery and generator.- the assembled device turned green and produced the startup tones.- full functionality was confirmed by activating the dual mode energy button with the clamping jaws open.- no abnormalities were noted with the device's activation button.- historical testing data was reviewed for this unit, and the unit passed all multi-tester testing, functional testing, and verification - the investigation found the device to function normally and within specifications.Based on the evidence available the reported condition of device difficult/intermittent activation; self activation; unit switch/kno b/button failure was not confirmed.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: 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: 17299988
• MDR Text Key: 318788664
• Report Number: 1717344-2023-00838
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: 10884521592841
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180149
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCDA39
• Device Catalogue Number: SCDA39
• Device Lot Number: 23480095X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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