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 Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

Procedure type: laparoscopic cholecystectomy.According to the reporter: the glass at the end broke.The case was not extended by more than 30 minutes.Caller could not provide information on whether the piece broke inside the patient.

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, do
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo, do
• Manufacturer Contact: sharon murphy ; 60 middletown ave.; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4009610
• MDR Text Key: 4957717
• Report Number: 9612501-2014-00237
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 176773P
• Device Lot Number: J4A2055X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1