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

Catalog Number 176773P

Device Problems Break (1069); Failure to Fire (2610)

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

Event Date 04/11/2014

Event Type  malfunction  

Event Description

Procedure type: laparoscopic cholecystectomy according to the reporter: physician stated the product didn't fire correctly as he was trying to use it.He pulled it out of the trocar and half of the piece of plastic (the clear dome on the tip) fell onto the patient drape.Scrub tech laid it on the mayo stand where the other half of the dome fell off.Nothing was left inside patient and no patient harm.There was no unanticipated tissue loss.There was no tissue damage.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.No device fragment fell into the patient.

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, qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3821204
• MDR Text Key: 20700311
• Report Number: 9612501-2014-00128
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 176773P
• Device Lot Number: J3B0055X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1