MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 012001

Device Problem Failure to Power Up (1476)

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

Event Date 09/03/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The reported condition for this incident was that during bariatric procedure there was a device power failure.The instrument was connected to pmv equipment and registered a mechanical fault.Visual inspection of the instrument noted the probe tip was broken.Visual and functional testing of the returned product confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the broken tip.The file was concluded to be a misuse of the product.Replication of the observed damage may occur when allowing the energized probe tip to come in contact with other metal objects such as other instruments, staples, or clips.Doing so may generate excess heat and weaken or break the probe tip.The instructions for use of this instrument state: avoid all contact between the tip of the instrument and metallic objects as it may cause damage and render the instrument inoperable.The event did not meet the regulatory reporting criteria.A review of the current historical complaint data reveals no trend for a device related failure for this condition.The file will be closed as a misuse of the product.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

The reporting person said that when the device was assembled (transducer and cable) the device did not work.No injury reported.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6024117
• MDR Text Key: 57262063
• Report Number: 1219930-2016-01072
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10884521058163
• UDI-Public: (01)10884521058163(17)180331(10)N3C0600X
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K971861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

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 Expiration Date: 03/31/2018
• Device Model Number: 012001
• Device Catalogue Number: 012001
• Device Lot Number: N3C0600X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR