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

Model Number	012001
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic living donor nephrectomy procedure.The tissue pad disengaged from the device while in use.The piece fell into the cavity and could be retrieved.The device was recognized by the generator and was activated.A new device was used to continue.There was no patient harm.

• 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: 7193854
• Report Number: 1219930-2018-00368
• Device Sequence Number: 1274884
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1