MAUDE Adverse Event Report: COVIDIEN LP SINGLE ULTRASONIC DISSECTOR

Model Number SCD391

Device Problems Detachment Of Device Component (1104); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that during a gastroenterostomy bypass, a red error light was observed and the device stopped working.A new dissector was replaced onto the system and the procedure was successfully completed.A piece of the active waveguide had disengaged from the dissector.The piece did not fall into the patient cavity and there was no patient injury.

Manufacturer Narrative

(b)(4).Date of follow-up report : 12/03/2015.One used sonicision cordless ultrasonic dissector was returned for evaluation.The visual inspection of the disposable hand piece revealed that the dissector torque adaptor was damaged.The customer reported that the device component disengaged.The reported condition was confirmed.The torque adaptor damage caused the waveguide to become unsecured and move backward into the rotation knob housing but stayed within the device body.Dropping the dissector on its tip or forcing the tip against a hard surface will destroy the torque adaptor which secures the waveguide in place.The damage made it difficult to disassemble the generator from the dissector without using external tools.Investigation identified the cause of the reported event to be user error.

• Brand Name: SINGLE ULTRASONIC DISSECTOR
• Type of Device: ULTRASONIC DISSECTOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5219713
• MDR Text Key: 31216576
• Report Number: 1717344-2015-00808
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

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: SCD391
• Device Catalogue Number: SCD391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1