MAUDE Adverse Event Report: COVIDIEN LP ULTRASONIC DISSECTOR

Model Number SCD396

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

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

The customer reported that during a hysterectomy, a red light was provided by the system and the system stopped working.The surgeon stopped using the device and while the surgical staff cleaned the dissector, a piece of the active waveguide disengaged.There was no patient involvement when this occurred.

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.

• Brand Name: ULTRASONIC DISSECTOR
• Type of Device: ULTRASONIC DISSECTOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder 80301
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4255062
• MDR Text Key: 4988483
• Report Number: 1717344-2014-00997
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2014

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 Expiration Date: 01/31/2019
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 256067X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• 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
• Treatment: ULTRASONIC REUSABLE GENERATOR - SERIAL # UNKNOWN
• Patient Age: 70 YR
• Patient Weight: 32