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

Catalog Number IAS12-100LPI

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code; gcj.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.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

On behalf of their customer, the distributor in (b)(6) reported an issue with the ias12-100lpi, airseal 12/100mm lpi port, lot 89319.It was reported that on (b)(6) 2020, during a robotic assisted partial nephrectomy procedure, the ias12-100lpi trocar was being used in airseal mode.The top of the airseal trocar came away during surgery to reveal the blue foam interior.The silencer was still attached when it fell onto the floor.Another airseal 12mm trocar was opened to replace this trocar.The gas tubing was used to maintain space while the other ias12-100lpi was set up.There was a loss of intra-abdominal gas / pressure during the procedure leading to a minor 10- minute surgical delay.There was no impact or injury to the patient and patient status is reported to be "good".No other information was available at this time.Although the device fell onto the floor and not into the patient, this report is being raised on the basis of previous us fda mdr reportings of similar malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Investigation of the reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified and a root cause not established.A review of the manufacturing documents from the device history record (dhr) could not be conducted as the documents could not be located.It is suspected that, based on the lot number, the device was manufactured prior to conmed acquiring the company making it.A two-year lot history review was conducted and found no other similar events reported for this lot number.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that if using the optional sound cap (8mm, 12mm): inspect sound cap blue foam and blue seal prior to use; use caution when inserting a sharp or large device through the blue sound cap seal.Inspect the sound cap after use for physical damage of any kind.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, mexico 31136 ; MX 31136
• MDR Report Key: 11139010
• MDR Text Key: 241669358
• Report Number: 3007305485-2021-00009
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 89319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Patient Sequence Number: 1