MAUDE Adverse Event Report: COVIDIEN VERSAPORT V2 BLADELESS OPT 12; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number ONB12STF

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Type  malfunction  

Event Description

According to the reporter: the seal tore and is leaking.Another device was used without further consequences.Gender, age and weight are not available.No patient injury or ill-effects.No medical intervention required.No unanticipated tissue loss, tissue damage or bleeding.No reinforcement material used.No extension to surgical time required.Nothing fell in the surgical cavity.Patient current status reported as recovered.The device will not be returned for evaluation, it was discarded by the customer.

Manufacturer Narrative

(b)(4).

• Brand Name: VERSAPORT V2 BLADELESS OPT 12
• 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: 4799663
• MDR Text Key: 5921812
• Report Number: 9612501-2015-00270
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONB12STF
• Device Catalogue Number: ONB12STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1