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); Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  malfunction  

Event Description

According to the reporter, during the nephrectomy surgery, the device was plugged into a generator but it was not cutting or sealing completely on a 5mm thick renal tissue and vessels, an activation tone was heard, no re-grasp alert, and there was an end-tone.Several good seals were completed and the device worked for about 1 hour before the problem presented.The device was also cleaned whenever necessary.The generator and battery were changed and it was confirmed that the problem was in the device.Replaced the scda39 and worked well on the same generator.There was no patient injury.Medtronic's initial evaluation of the incident device found fractured waveguide.

Manufacturer Narrative

Concomitant product: scgaa, reusable generator a scgaa (lot#568122x) evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the dissector had a fractured waveguide.The waveguide was not returned with the device.It was reported that the device had a coagulation issue and cutting issue.The reported issues were confirmed.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.The instructions included with this device provide the following guidance: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in product damage, such as a broken blade.Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.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: 19167390
• MDR Text Key: 341675869
• Report Number: 1717344-2024-01013
• 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: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• 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: 31030028X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2023
• 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
• Patient Age: 72 YR