MAUDE Adverse Event Report: COVIDIEN SONCICISION ULTRASONIC DISSECTOR; INSTRUMENT,ULTRASONIC SURGICAL

Catalog Number SCD396

Device Problems Bent (1059); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 10/05/2017

Event Type  malfunction  

Event Description

During the procedure, the device began to fail.The surgeon removed the device to see what was wrong and found that the tip was bent.After inspection the tip fell off.

• Brand Name: SONCICISION ULTRASONIC DISSECTOR
• Type of Device: INSTRUMENT,ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr; boulder CO 80301
• MDR Report Key: 6961281
• MDR Text Key: 89711531
• Report Number: 6961281
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SCD396
• Device Lot Number: 71660226X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• 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
• Patient Age: 73 YR