MAUDE Adverse Event Report: COVIDIEN VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179078P

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: 5mm flip top converter seal is coming detached during case.

Event Description

Additional information provided by the account: the procedure was a sleeve gastrectomy.There were no adverse events as a result of the defect.Nothing fell into the patient.Surgical time was not extended.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary:post market vigilance (pmv) led an evaluation of device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The obturator and the trocar assembly were received.Visual examination of the trocar assembly revealed the flip top seal was not disengaged.Functionally, the flip top converter did not latch properly.The obturator was inserted into the trocar with no binding or difficulty.The instrument was applied to test media; the knife blade cut cleanly and completely through the media, allowing the cannula to pass through.In addition, the trocar passed the air leak test.A review of the device history record indicates this device lot number was released meeting all quality specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Replication of the reported condition was due to a component error.The material from the supplier was found to be defective and a product enhancement has been implemented.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 5004355
• MDR Text Key: 24368583
• Report Number: 9612501-2015-00492
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 179078P
• Device Catalogue Number: 179078P
• Device Lot Number: J4E1933X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1