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

Model Number SCD396

Device Problems Material Fragmentation (1261); Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

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 the procedure, all devices were being used on dense, thick, fibrous tissue.Four total fibroids were resected.Multiple error tones were experienced with each device leading up to their eventual failure modes.The first 2 handles had blades that broke off within the patient and both broken blades were successfully retrieved.The third handle began producing immediate error tones in open space, but the blade remained intact.A fourth handle was issued and used successfully without incident to complete the case.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: 8375904
• MDR Text Key: 137368250
• Report Number: 1717344-2019-00249
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20884521052663
• UDI-Public: 20884521052663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

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 Expiration Date: 10/21/2023
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 82840126X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/27/2019
• Date Device Manufactured: 10/22/2018
• 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: 58 YR
• Patient Weight: 58