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

Model Number ONB5STF

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: laparoscopic right hemicolectomy.According to the reporter: upon removing surgical instruments through the trocar, strange sound was heard.Stopped using the device and opened another trocar to complete the procedure.After the procedure, they confirmed upper seal damaged.Operating time not extended.Nothing fell into the cavity.No patient harm.

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; 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: 4735525
• MDR Text Key: 16394810
• Report Number: 9612501-2015-00228
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: ONB5STF
• Device Catalogue Number: ONB5STF
• Device Lot Number: J4M1249X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR