MAUDE Adverse Event Report: COVIDIEN BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number 176626P

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

According to the reporter: the foam collar fell into the abdomen and was recovered just before they began to close.When i asked the surgeon about it, she said it was a very complicated case with a large patient and the issue was not the result of a product failure.Patient status is good.The difficulty did not result in a unintended colostomy, formal laparotomy, re-operation etc.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.Foam collar on trocar fell into the patient and was retrieved.

Manufacturer Narrative

(b)(4).

• Brand Name: BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP
• 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: 4838584
• MDR Text Key: 5944219
• Report Number: 9612501-2015-00307
• Device Sequence Number: 1
• Product Code: GDH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 176626P
• Device Catalogue Number: 176626P
• Device Lot Number: J5C1759X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1