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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 Foreign Body In Patient (2687)
Event Date 11/18/2021
Event Type  Injury  
Manufacturer Narrative
Additional product code; gcj.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 (b)(4) received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, lot 202106114, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates during a robot assisted gastrectomy, it was found the tip of trocar cracked at the time of postoperative closure.Debris may remain in the patient's body.It is noted the procedure was successfully completed with no reported delay.Additional information received notes the surgeon is not sure when the device was broken.Grasping forceps, needleholder, signia (brand name), echeron (brand name) instruments had been inserted/withdrawn using the port prior to the issue being detected.It is noted there is a chip missing out of the tip and the piece had not been found.This report is being raised on the basis of injury as it is noted debris may remain in the patient¿s body.
 
Manufacturer Narrative
Additional product code; gcj.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 (b)(4) received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, lot 202106114, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates during a robot assisted gastrectomy, it was found the tip of trocar cracked at the time of postoperative closure.Debris may remain in the patient's body.It is noted the procedure was successfully completed with no reported delay.Additional information received notes the surgeon is not sure when the device was broken.Grasping forceps, needleholder, signia (brand name), echeron (brand name) instruments had been inserted/withdrawn using the port prior to the issue being detected.It is noted there is a chip missing out of the tip and the piece had not been found.This report is being raised on the basis of injury as it is noted debris may remain in the patient¿s body.
 
Event Description
On behalf of the customer, conmed japan received notice of reported issues with the ias12-100lpi, airseal 12/100mm lpi port, lot 202106114, that (b)(6) hospital recently experienced on (b)(6) 2021.Information received indicates during a robot assisted gastrectomy, it was found the tip of trocar cracked at the time of postoperative closure.Debris may remain in the patient's body.It is noted the procedure was successfully completed with no reported delay.Additional information received notes the surgeon is not sure when the device was broken.Grasping forceps, needleholder, signia (brand name) echeron(brand name) instruments had been inserted/withdrawn using the port prior to the issue being detected.It is noted there is a chip missing out of the tip and the piece had not been found.This report is being raised on the basis of injury as it is noted debris may remain in the patient¿s body.
 
Manufacturer Narrative
D2: additional product code; gcj.H10: the investigation of the customer's reported issue finds it to be confirmed based on evaluation of returned device.Conmed received one ias12-100lpi in opened original packaging.The lot number of the device was verified based on return packaging.A visual inspection was performed, the trocar is broken at the distal end.The pieces that broke off were not returned with the device.The returned device exhibits the reported claim, nevertheless a root cause cannot be established.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.(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.
 
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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
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 Key13005063
MDR Text Key285218608
Report Number3007305485-2021-00433
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143404
Number of Events Reported1
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 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIAS12-100LPI
Device Lot Number202106114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/19/2021
Initial Date FDA Received12/14/2021
Supplement Dates Manufacturer Received01/19/2022
Supplement Dates FDA Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient EthnicityNon Hispanic
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