MAUDE Adverse Event Report: COVIDIEN VERPRT PLUS V2 5MM-11MM TRC; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number 179095P

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Emphysema (1832)

Event Date 06/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: prolapse by laparo.According to the reporter: a sub cutaneous emphysema appeared without any reason.The insufflation was stopped.There were no extension of the surgery time, no bleeding, no tissue loss, no reinforcement material used.

Manufacturer Narrative

(b)(4).

• Brand Name: VERPRT PLUS V2 5MM-11MM TRC
• 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: 4881367
• MDR Text Key: 19883797
• Report Number: 9612501-2015-00353
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 179095P
• Device Catalogue Number: 179095P
• Device Lot Number: J5A0760X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 19