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

Model Number SCDA39

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)

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); scg, scg sonicision generator x1 (sn:unknown); scg, scg sonicision generator x1 (sn:unknown); scg, scg sonicision generator 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 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.

Manufacturer Narrative

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the jaw liner was melted.There were some pieces missing.Functionally, the jaw liner damage was caused by the device jaws being clamped and activated multiple times with too little or no tissue present in the jaws.Extended activation under this condition will cause the jaw liner to melt and become damaged.Manufacturing records for this lot were reviewed and no non-conformances were found that could have contributed to the failure.No defects or damage were observed in the packaging returned that could have contributed to the reported defect.Manufacturing does 100% inspection during the assembly and packaging processes.The defect sample would have been rejected if found prior to shipping, had it been an assembly defect.It was reported that the device had any issue with coagulating, had a cutting issue and received a red light and would not activate during use.A potentially related device issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: jaw liner degrades.Visual inspection noted the unit had a jaw liner detachment failure.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: not to activate the instrument with the clamping jaw closed unless there is tissue present, as doing so may damage the device jaws.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, d10, g3 d10 concomitant products: scda39, ultrason dissect scda39 curved jaw 39cm (lot#20250108x) scg, scg sonicision generator x1 (sn:(b)(6)) scg, scg sonicision generator x1 (sn:20250108x) scg, scg sonicision generator 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 begun 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.

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.

Manufacturer Narrative

Additional information: g3 correction: b5, h6 (fdp/imf/ime: c172009 modified surgical procedure/ f1906 modified surgical procedure/ e2009 lacerations).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.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.

• 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: 17109981
• MDR Text Key: 317030193
• Report Number: 1717344-2023-00701
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: 10884521592841
• 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,Followup,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCDA39
• Device Catalogue Number: SCDA39
• Device Lot Number: 20250108X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male