MAUDE Adverse Event Report: COVIDIEN BLADELESS VP 15MM ST W/ FIXATION; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number NB15STF

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

According to the reporter: the reducing (white ring) not clipping onto the trocar.

Manufacturer Narrative

(b)(4).Initial report sent to fda on 06/19/2015.

Manufacturer Narrative

(b)(4).Based on review of the information provided by the account, this event has been determined to be a non-reportable incident.The file has been updated from a malfunction to a complaint.

• Brand Name: BLADELESS VP 15MM ST W/ FIXATION
• 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 ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4856445
• MDR Text Key: 5808760
• Report Number: 9612501-2015-00327
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081169
• 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: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB15STF
• Device Catalogue Number: NB15STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1