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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the waveguide was found to be broken.Functional testing found he assembled device returned a green light and produced a welcome tone.The assembled device immediately alarmed when activated.The waveguide was inspected under magnification and the origin of the crack was identified.Investigation personnel concluded that the titanium waveguide became cracked from continued use after it may have come in contact with a metallic object.The crack propagated until the waveguide fractured.It was reported that the device did not operate in the coagulation mode, received a red light and would not activate during use.The reported issue 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 unintended damage to tissue and/or device failure.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during nephrectomy, at the beginning of use, the device was difficult to activate due to it presented failure after the surgeon's activation on the tissue, the clamp did not perform seal, sound signal and light signal present.They changed the generator and battery but still the same.They replaced the device to complete the procedure.Based on the investigation, the crack propagated until the waveguide fractured.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: 11252729
• MDR Text Key: 231312608
• Report Number: 1717344-2021-00149
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 72860029X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2021
• 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 Age: 67 YR