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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC
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CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number IAS12-100LPI
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Additional product code; gcj.The device in question has been received by conmed and has entered into the evaluation process.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, lot 202012225, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates ¿during the operation, it was confirmed that the silencer valve was partially broken and fell into the abdominal cavity.The debris was immediately retrieved so that there were no effects such as delays in surgery etc.Dr said that it was closed when the forceps were taken in and out and seems that keen instruments were not put in and out too.¿ it is noted the procedure was successfully completed with no alternate device used.There is no indication of impact or injury to the patient.Additional information received indicates the issue occurred during robot-assisted laparoscopic radical prostatectomy.¿keen¿ was clarified to mean devices which have sharp tip or edge.The surgeon said he is always sure to insert or take out device like forceps with edge closed to prevent breaking sound cap.No other information was provided.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the port piece fell into the patient but was removed.
 
Manufacturer Narrative
Investigation of the customer's complaint is confirmed.Conmed received the sound cap of one ias12-100lpi returned opened in unoriginal packaging.The lot number of the part could not be verified as no packaging was returned.A visual inspection found the blue duckbill of the sound cap was damaged.A small fragment of the duckbill was torn, the blue fragment was returned.Other defects and abnormalities could not be found on the returned sound cap.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.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.Also, per the ifu, the user is advised that failure to properly follow the instructions for use can lead to serious surgical consequences.If using the optional sound cap (8 mm, 12 mm), inspect sound cap foam and 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.
 
Event Description
On behalf of the customer, conmed japan received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, lot 202012225, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates ¿during the operation, it was confirmed that the silencer valve was partially broken and fell into the abdominal cavity.The debris was immediately retrieved so that there were no effects such as delays in surgery etc.Dr said that it was closed when the forceps were taken in and out and seems that keen instruments were not put in and out too.¿ it is noted the procedure was successfully completed with no alternate device used.There is no indication of impact or injury to the patient.Additional information received indicates the issue occurred during robot-assisted laparoscopic radical prostatectomy.¿keen¿ was clarified to mean devices which have sharp tip or edge.The surgeon said he is always sure to insert or take out device like forceps with edge closed to prevent breaking sound cap.No other information was provided.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the port piece fell into the patient but was removed.
 
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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
MDR Report Key12480550
MDR Text Key271666999
Report Number3007305485-2021-00374
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K143404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/22/2023
Device Catalogue NumberIAS12-100LPI
Device Lot Number202012225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Date Manufacturer Received10/04/2021
Patient Sequence Number1
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