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

Model Number 012033

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: ladg - lap assisted distal gastrectomy.According to the reporter: during procedure, the tissue pad was shaky (loose) and tissue slipped off the jaws upon grasping.Another used to continue the procedure.No patient harm.Procedure: ladg.Operating time not extended.No additional tissue resection or tissue damage.Nothing fell into the cavity.No bleeding.The device was recognized by generator.The device was activated.

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.Visual examination of the instrument noted no abnormalities.Functional evaluation noted that the jaw operated properly upon actuation of the handle but failed a grasping test.The jaw was loose when the handle was compressed.The instrument was energized at full power for one minute and registered a mechanical fault.The device was disassembled and damage to the probe housing grove was observed.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged probe housing groove.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.(b)(4).

• 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: 4963267
• MDR Text Key: 23395987
• Report Number: 1219930-2015-00701
• Device Sequence Number: 1
• Product Code: LFL
• 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: Other
• Type of Report: Followup
• Report Date: 07/28/2015

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: 05/31/2018
• Device Model Number: 012033
• Device Catalogue Number: 012033
• Device Lot Number: N3E0298X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1