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

Catalog Number SCD396

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

Product was open to field with bent metal prongs where the battery plugs in.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN/MEDTRONIC; 5920 longbow dr.; boulder CO 80301
• MDR Report Key: 6167107
• MDR Text Key: 62141210
• Report Number: 6167107
• 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: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SCD396
• Device Lot Number: 50790140X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2016
• 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