MAUDE Adverse Event Report: COVIDIEN VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1; DISPOSABLE SURGICAL ACCESS DEVICE

Catalog Number VS101012P

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: the customer reports that during the procedure, the ring of the device dislodged.Another device was used to complete the procedure successfully.

Manufacturer Narrative

(b)(4).

• Brand Name: VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3810337
• MDR Text Key: 12211021
• Report Number: 9612501-2014-00099
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2014

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: 03/31/2018
• Device Catalogue Number: VS101012P
• Device Lot Number: J3C0195X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1