MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT; AUTOSONIX SHEARS

Model Number 012001

Device Problems Device Slipped (1584); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during the procedure, the device would not cut smoothly and also would not grasp tightly enough.Another used to continue the procedure.No patient harm.

Manufacturer Narrative

(b)(4).

• Type of Device: AUTOSONIX SHEARS
• 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: 4338174
• MDR Text Key: 12853313
• Report Number: 1219930-2014-01161
• 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,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 012001
• Device Catalogue Number: 012001
• Device Lot Number: N3J1024X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1