MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VISIPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 176673P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Peritonitis (2252); No Code Available (3191)

Event Date 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to reporter, during a laparoscopic abdominal wall hernia procedure, this port was used as the first port.This product was punctured without abdominal gas pressure under left hypochondrium.While carefully perforating the peritoneum, gas was put into the abdominal cavity after the peritoneum opened slightly.After that, there was no bleeding and finished the procedure without problem.The next day, the patient had panperitonitis and was reoperated with open surgery due to perforation of the colon.The location was just under the trocar.The event occurred/was noticed after the surgery.Current patient condition: under observation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: as per the additional information received, the patient was intubated and be performed dc defibrillation twice.Intraperitoneal washing, suture closure of puncher section, mesh removal was performed by open surgery.Patient status: the patient recovered.

• Brand Name: VISIPORT PLUS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6900299
• MDR Text Key: 87616670
• Report Number: 1219930-2017-07485
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K935086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176673P
• Device Catalogue Number: 176673P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1