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

Catalog Number IAS12-100LPI

Device Problems Break (1069); Crack (1135); Material Fragmentation (1261)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

On behalf of the customer, conmed (b)(4) received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, unknown lot, that (b)(6) cancer center hospital recently experienced on (b)(6) 2021.Information received indicates that the tip of the trocar was cracked and broken, fragments fell off when removed from the patient's body(no drop into the patient's body).It was noted there was no impact or injury to the patient and the procedure was successfully completed with no reported delay.Clarification received notes the issue occurred during a thoracoscopic subtotal esophagectomy.There was no resistance in placing / inserting the port and there is no discomfort.A harmonic hd (jnj) instrument had been inserted/withdrawn using the port.Although asked.The reporter provided no other information to conmed (b)(4).This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device tip broke off after use and no piece fell into patient.

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, conmed japan received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, unknown lot, that aichi cancer center hospital recently experienced on (b)(6) 2021.Information received indicates that the tip of the trocar was cracked and broken, fragments fell off when removed from the patient's body(no drop into the patient's body).It was noted there was no impact or injury to the patient and the procedure was successfully completed with no reported delay.Clarification received notes the issue occurred during a thoracoscopic subtotal esophagectomy.There was no resistance in placing / inserting the port and there is no discomfort.A harmonic hd (jnj) instrument had been inserted/withdrawn using the port.Although asked.The reporter provided no other information to conmed japan.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device tip broke off after use and no piece fell into patient.

Manufacturer Narrative

The investigation of the customer's reported issue finds it to be confirmed based on evaluation of the returned used device.Conmed received one ias12-100lpi in unoriginal packaging.The lot number of the device could not be verified as the original packaging was not returned.A visual inspection was performed, the distal tip of the trocar is broken.All of the broken pieces were not returned.The returned device exhibits the reported claim, nevertheless a root cause cannot be established.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.A two-year review of complaint history revealed there has been a total of 30 complaints, regarding 30 devices, for this device family and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised to 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.

• Brand Name: AIRSEAL 12/100MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 13001539
• MDR Text Key: 286750524
• Report Number: 3007305485-2021-00430
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic