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

Model Number SCGAA

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant products: scda39, ultrason dissect scda39 curved jaw 39cm, (lot #20250108x) scda39, ultrason dissect scda39 curved jaw 39cm, (lot #20250108x) scg, scg sonicision generator x1, (sn #unknown) scb, scb sonicision battery pack x1, (sn #unknown) 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 procedure, the device failed to activate.After fifteen minutes, it began failing to activate with a red light on the generator.The surgeon allowed the advisor to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.

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 procedure, the device failed to activate after fifteen minutes it begin to fail to activate with a red light on the generator.The surgeon allowed the to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.No part of the device was detached.The procedure stopped for 15 minutes.The procedure was completed via product exchanged.

Event Description

According to the reporter, during procedure, the device failed to activate after fifteen minutes it begin to fail to activate with a red light on the generator.The surgeon allowed the to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.No part of the device was detached.A new dissector was used with the same generator and battery and it worked successfully.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.

Manufacturer Narrative

Additional information: g3 correction: a1, b5, d4 (model and catalog number, udi), g4 (510k), h6 (fdp/imf/ime: (b)(6) modified surgical procedure/ f1906 modified surgical procedure/ e2009 lacerations).New information has been received, and reassessment of the complaint found that it is no longer a reportable event.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.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: 17125148
• MDR Text Key: 317150301
• Report Number: 1717344-2023-00709
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521592865
• UDI-Public: 10884521592865
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K180149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCGAA
• Device Catalogue Number: SCGAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male