MAUDE Adverse Event Report: COVIDIEN VISIPORT PLUS 5-11MM W FIXATION CANNULA; DISPOSABLE SURGICAL ACCESS DEVICE

Catalog Number 176673PF

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2014

Event Type  Injury  

Event Description

Procedure type: gynecology.According to the reporter: when the dr placed the visiport into the patient, he felt that it was not going through properly so he tried to remove it so the piece of the plastic tip dislodged inside the patient.They could not find the piece of the plastic tip so ti might still be inside the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: VISIPORT PLUS 5-11MM W FIXATION CANNULA
• 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: 3800236
• MDR Text Key: 4527164
• Report Number: 9612501-2014-00132
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K935086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 176673PF
• Device Lot Number: J3L0258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other