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

Model Number SCD396

Device Problems Failure to Deliver Energy (1211); Mechanical Jam (2983)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during video bariatric surgery, when the dissector was activated to seal the vessel and the jaws were difficult to open, at the time of sealing the stomach tissue, the trigger was locking and not sealing.They tried to change the battery and the generator but still had the same issue.Then, they tried to change the dissector instead and it worked successfully.There was no patient injury.

Manufacturer Narrative

Additional information: b5, b7(removed obesity), d9, e1(phone number), g1(manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email and phone number), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found no notable conditions.Functional testing was performed with the returned dissector using a test lab generator and battery.The device activated, but would fail when the jaw was closed.It was reported that the device did not operate in the coagulation mode.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.The failure is consistent with the audio speaker coming loose out of its housing because the speaker was not pushed deep enough into the housing receptacle after adhesive application.Activating the device with the jaws closed causes the compression spring to come into contact with bare speaker leads resulting in a short.Internal process improvements have been initiated to mitigate this issue.It was also reported that the jaws of the device locked on tissue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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 video bariatric surgery when the dissector was activated to seal the vessel and the jaws were difficult to open.At the time of sealing the stomach tissue, the trigger was locking and not sealing.No tissue damage or blood loss was noted.They tried to change the battery and the generator but still had the same issue.Then they tried to change the dissector instead and it worked successfully.There was no patient injury.

• 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, CO 55112 ; 7635265677
• MDR Report Key: 12908392
• MDR Text Key: 281509172
• Report Number: 1717344-2021-01593
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20884521052663
• UDI-Public: 20884521052663
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101797
• 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
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 01270230X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• 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