MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG AUTOSONIX; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 012001

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during procedure, the device started cutting tissue poorly.New device was used to continue.No patient harm.

Manufacturer Narrative

Device evaluation: post market vigilance led an evaluation of one device.Each instrument registered a mechanical fault.The instrument was disassembled; a crack was noticed in the proximal portion of each probe shaft.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cracked probe shaft may occur when the probe shaft makes contact with the out tube while the system was energized.The information for use for this product states: avoid using the ultra shears* device as a lever, either while dissecting or while activating the instrument.Added stress to the tip may cause the probe to touch in the inner tube portion of the instrument, resulting in mechanical failure and/or rendering the instrument inoperable.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AUTOSONIX
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7083367
• MDR Text Key: 93875430
• Report Number: 1219930-2017-09381
• 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,Followup
• Report Date: 01/23/2018

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: 06/30/2019
• Device Model Number: 012001
• Device Catalogue Number: 012001
• Device Lot Number: N4F1472X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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