MAUDE Adverse Event Report: COVIDIEN VISPRT PLUS 11MM OBTR + 5MM-12MM SEAL RT; DISPOSABLE SURGICAL ACCESS DEVICE

Catalog Number 176773P

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

According to the reporter: the lens of the visiport broke prior to usage.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: VISPRT PLUS 11MM OBTR + 5MM-12MM SEAL RT
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4041879
• MDR Text Key: 4862883
• Report Number: 9612501-2014-00257
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K963115
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 176773P
• Device Lot Number: J4A2055X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1