MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 5/120MM PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS5-120LP

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Inspection found that the outer cannula broke approximately 8 inches from the distal end of the cannula.Inspection of the break area found that when viewed with unaided vision, the break was smooth.Magnification found that the break area occured in between the "teeth" where the cannula is thinnest.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 8 complaints, regarding 8 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: warnings: failure to properly follow the instruction for use can lead to serious surgical consequences.Precautions: use extreme caution during airseal access port insertion.Improper use of this product can result in life-threatening injury to internal organs and vessels.Ensure that adequate pneumoperitoneum or pneumorectum is established.Ensure that the patient is properly positioned so that organs are away from the penetration site.Direct the airseal access port's tip away from significant vessels and organs.Do not use excessive downward force.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the ias5-120lp, airseal 5mm access port and low profile obturator with bladeless optical tip, 120mm length, qty 6, device was being removed from the patient when the device broke into 2 pieces.The outer cannula broke off and remained in patient.Clamps were needed to remove the outer cannula which remained intact in the patient's fascia after breaking.This event caused a 15-minute delay in the procedure.It is reported that there was no injury to the patient.The procedure had already been completed; this event took place at the end of the procedure.This report is being raised on the basis of device malfunction with potential of injury upon reoccurrence.

• Brand Name: AIRSEAL 5/120MM PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 7812332
• MDR Text Key: 118113035
• Report Number: 1320894-2018-00186
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Catalogue Number: IAS5-120LP
• Device Lot Number: 66218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1