MAUDE Adverse Event Report: COVIDIEN LLC SONICISION 39 CM DISSECTOR; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCD396

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/13/2016

Event Type  malfunction  

Event Description

Product stopped working abruptly during case.

• Brand Name: SONICISION 39 CM DISSECTOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LLC; 60 middletown ave; north haven CT 06473
• MDR Report Key: 6784741
• MDR Text Key: 82375495
• Report Number: 6784741
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2017

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: No Information
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Other Device ID Number: 060285
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1