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

Model Number NB15STF

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

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

Event Date 12/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 03/23/2015.

Event Description

According to the reporter: a small seal on the 5mm "toilet seat" was dislodged and fell onto the floor.No other details.

Manufacturer Narrative

(b)(4).

• 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: 4380454
• MDR Text Key: 13103459
• Report Number: 9612501-2015-00003
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1