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

Model Number SCD396

Device Problems Break (1069); Loss of Power (1475); Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

We replaced the battery twice and dr states "it's not the battery.The actual instrument is broken, stopped working".Also, part of the non-disposable piece that fits on top will not come off after several attempts.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow dr.; boulder CO 80301
• MDR Report Key: 7909451
• MDR Text Key: 121715492
• Report Number: 7909451
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

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: 82070334X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA