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

Model Number NB15LGF

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  

Event Description

According to the reporter: small seal on the 5mm "toilet seat" dislodged and fell onto the floor.No other details.The difficulty did not result in any tissue damage or patient injury.

Manufacturer Narrative

(b)(4).Initial report sent to fda on 02/24/2015.

Manufacturer Narrative

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

• Brand Name: BLADELESS VP 15MM LG 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: 4538078
• MDR Text Key: 5537751
• Report Number: 9612501-2015-00103
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: NB15LGF
• Device Catalogue Number: NB15LGF
• Device Lot Number: J4C0554X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1