MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY AIRSEAL 8/120MM PORT; INSUFFLATOR, LAPAROSCOPIC

Model Number IAS8-120LP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/24/2021

Event Type  malfunction  

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, the conmed representative reported issues with the ias8-120lp, airseal 8/120mm port, lot 202106024, that dr.(b)(6)of (b)(6) general health/ women¿s and babies hospital recently experienced on (b)(6) 2021 (patient (b)(6)).Information received indicates ¿inner seal of trocar separated from trocar when instrument removed from patient's abdomen.No retained material in patient.Trocar assessed, all pieces intact.¿ there is no indication of impact or injury to the patient.Additional information has been requested, but none received to date.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 one ias8-120lp returned opened in original packaging.The reported lot number of the device, 202106024, was verified.A visual inspection found only the sound cap of the ias8-120lp was returned.The sound reduction duckbill had detached completely from the sound cap, the reduction foam and the retainer was still on the cap and did not detach.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.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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, the conmed representative reported issues with the ias8-120lp, airseal 8/120mm port, lot 202106024, that dr.(b)(6) of (b)(6) hospital recently experienced on (b)(6) 2021 (patient (b)(6)).Information received indicates ¿inner seal of trocar separated from trocar when instrument removed from patient's abdomen.No retained material in patient.Trocar assessed, all pieces intact.¿ there is no indication of impact or injury to the patient.Additional information received noted: dr.Noticed it when withdrew grasper from the trocar, it was coming out.The seal was intact.Dr.Removed the cap, then removed the seal and opened another cap to replace the broken one.Not sure how long into the procedure this happened.The seal started to detach while trocar was in patient, they noticed it removed the cap and then removed the seal so that it wasn¿t attached to the patient.The port was in patients right upper quad.There was nothing special noted about patient¿s anatomy.There was no issue placing the port & nothing unusual noted about port.A blunt probe, grasper and possibly a needle driver with a needle were used in/around trocar.From sus voluntary event report # mw5103557 - inner seal of trocar separated from trocar when instrument was removed from patient¿s abdomen during laparoscopic procedure.No material retained in the abdomen & all pieces accounted for.No injury to patient.The additional clarification received does not change the filing of this report.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.

• Brand Name: AIRSEAL 8/120MM 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 Key: 12467024
• MDR Text Key: 271250347
• Report Number: 3007305485-2021-00372
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)240601(10)202106024
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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 Expiration Date: 06/01/2024
• Device Model Number: IAS8-120LP
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202106024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/15/2021
• Patient Sequence Number: 1