MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON OPT BL VP V2 5MM STD W/FX; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number ONB5STF

Device Problems Melted (1385); Fitting Problem (2183); Device Dislodged or Dislocated (2923)

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

Event Date 01/07/2015

Event Type  malfunction  

Event Description

According to the reporter: there was difficulty with cardinal insufflation tubing remaining attached to the trocar during procedure as well with sonicision (a covidien product) fitting down the trocar cannula shaft.This caused the cannula tip to become dislodged in the patient (but retrieved by the surgeon) potentially by the tip being melted off (from the heat of sonicison instrument).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 03/20/2015.Additional information received from the account.Lot number was provided.(b)(4).A new mdr will be sent with the correct manufacturing report number due to the updated facility information.

Manufacturer Narrative

(b)(4).Follow up report sent to fda on 03/20/2015.Mdr will be submitted under corrected mfr report #9612501-2015-00160.

Manufacturer Narrative

(b)(4).

• Brand Name: OPT BL VP V2 5MM STD W/FX
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN; zona franca; carretara san isidro km17; santo domingo CT 06473 ; DR 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4434188
• MDR Text Key: 5377051
• Report Number: 1219930-2015-00047
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2015

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: 10/31/2019
• Device Model Number: ONB5STF
• Device Catalogue Number: ONB5STF
• Device Lot Number: J4K1567X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2015; 03/20/2015; 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1