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

Model Number SCD396

Device Problems Failure to Deliver Energy (1211); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the tip of the waveguide was broken off and fractured.The assembled device returned a green light and a welcome tone, but im mediately returned a red led indicator with an error tone (alarm activation) when the device was activated.This characteristic indicated that the device was not functional.It was reported that the device did not operate in the coagulation mode.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the waveguide had contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc.) during activation.Contact with metal objects during use will cause the active blade to crack and may eventually break off.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: visually inspect all system components for breaks, cracks, nicks, or other damages prior to use.Do not use damaged components.Use of damaged components may result in injury to the patient or user.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the device presented difficulties to seal the vessels.Another forceps was used to complete the procedure.The medtronic initial investigation of the disposable device revealed that the tip of the waveguide was broken off and fractured.The broken piece was returned.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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10497485
• MDR Text Key: 208941114
• Report Number: 1717344-2020-00997
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 91970118X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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: 37 YR