MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN AUTOSONIX; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 012001

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic living donor nephrectomy, upon using the device, the device was not able to cut the tissue.The procedure was completed with another device.No patient injury.

• Brand Name: AUTOSONIX
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8505864
• MDR Text Key: 141793092
• Report Number: 1219930-2019-02255
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521058163
• UDI-Public: 10884521058163
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2019

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: 07/31/2019
• Device Model Number: 012001
• Device Catalogue Number: 012001
• Device Lot Number: N4G0087X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/11/2019
• Date Device Manufactured: 07/02/2014
• 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