MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL AUTOSONIX ULTRA SHEARS LONG; AUTOSONIX SHEARS

Catalog Number 012033

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

Procedure: ladg - lap assisted distal gastrectomy.According to the reporter: the device would not grasp the tissue firmly with the jaw.The tissue seemed to slip off the jaw.

Manufacturer Narrative

(b)(4).

• Brand Name: AUTOSONIX ULTRA SHEARS LONG
• Type of Device: AUTOSONIX SHEARS
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4048048
• MDR Text Key: 4909321
• Report Number: 1219930-2014-00653
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 012033
• Device Lot Number: N1D0817X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1