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

Model Number	012001
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
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, during laparoscopic living donor nephrectomy, the device did not work normally and the tissue could not be cut.They used another product to continue.There was no patient injury.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The jaw operated properly upon actuation of the handle but failed a grasping test.The device was disassembled and damage to the probe housing grove was observed.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 damage to the probe housing groove is consistent with excessive material or an obstruction being compressed in the jaws as the trigger is connected to the groove and the jaws are closed.Any damage to the groove interface will result in the handle bottoming out and the jaws not closing completely.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AUTOSONIX
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7937999
• Report Number: 1219930-2018-05333
• Device Sequence Number: 2305692
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 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: 10/19/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1