MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS12-100LPI

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Secondary fda product code is (b)(4).Manufacturer narrative: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental, and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, ias12-100lpi, was being used during a laparoscopic assisted apr on (b)(6) 2020 when the small bowel was sucked up into the port.The port did not have any devices inserted at the time.This caused a small tear to the bowel, which required to be oversewn for medical intervention/repair.Per the reporter's form that was submitted, this was not considered an injury, rather only medical intervention.Also, the reporter did not consider this a fault or failure of the device due to the need for better placement of the port, and/or possible using a small millimeter sized port.The procedure was completed as planned, and there was no report of injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The alleged failed ias12-100lpi is not expected to be returned for evaluation and review.This complaint of failed device is unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have not been reviewed because the lot number of the device was not known.The lot history of the device was not conducted because the lot number of the device was not known.(b)(4).Per the instructions for use, the user is advised the following: warnings: failure to properly follow the instructions 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12/100MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 10780872
• MDR Text Key: 214817642
• Report Number: 3007305485-2020-00469
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

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 Catalogue Number: IAS12-100LPI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 12/10/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 92