MAUDE Adverse Event Report: COVIDIEN LP SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCDA39

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

When initiating the power button on the sonicision curved jaw cordless ultrasonic dissector, the device did not operate as expected.There was no noise or movement of the jaws.The sonicision dissector requires an unsterile battery to be inserted into the end of the tool, via one of the sterile pieces which is removed by the circulator once inserted so there was no way to trouble shoot the device without contamination.Report from room staff noted that "the battery was difficult to remove once taken off the field, but the battery was inserted and used without issue on the replacement handpiece.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13415410
• MDR Text Key: 284811883
• Report Number: 13415410
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SCDA39
• Device Lot Number: 12110053X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Male