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

Model Number	012001
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The instrument registered a mechanical fault.The instrument was disassembled; a crack was noticed in the proximal portion of the 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 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.Based on the evidence available the reported condition was confirmed.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.
Event or Problem Description
According to the reporter, during a laparoscopic living donor nephrectomy, the device started cutting the tissue poorly and a strange noise was heard.A new device was used to complete the procedure.There was no patient injury reported.

• Brand Name: AUTOSONIX
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7124405
• Report Number: 1219930-2017-10129
• Device Sequence Number: 1259879
• Product Code: LFL
• UDI-Device Identifier: 10884521058163
• UDI-Public: 10884521058163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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
• Operator of Device: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1