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

Model Number IAS12-100LPI

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Please note this report is being resubmitted following an unsuccessful submission attempt on 22june2021 due to a system error.Investigation of the reported event is inconclusive.Although originally expected, it has been determined that the device in question has been discarded by the facility.No photographic evidence was provided.Therefore, the reported failure cannot be verified, & root cause cannot be identified.The device history record manufacturing documents have been reviewed & found no abnormalities that would contribute to this issue.A two-year lot history review was conducted & found this is the only complaint this lot number & failure mode.A two-year review of complaint history for similar failure modes revealed there has been a total of 2 complaints, regarding 2 devices, for this device family & failure mode.During this same time frame (b)(4) devices have been manufactured & 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 & use of this device if using the optional sound cap (8 mm,12 mm): inspect sound cap blue foam and blue seal prior to use.Use caution when inserting a sharp or large device through the cannula.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 facility, the conmed representative reported issues with the ias12-100lpi, airseal 12/100mm lpi port, lot 202006165, that was recently experienced by (b)(6) hospital on (b)(6) 2021.The information received indicates rubber gasket inside 12mm airseal sound cap/muffler came off during procedure and fell into the patient.Gasket was recovered from inside patient.Occurred when 12mm stapler was inserted with sound cap still attached.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 notes the belief was that 12mm stapler was being used with the silencer cap in place.The port was located mid-abdomen and there was nothing unusual or of special concern noted regarding the patients anatomy.This incident is being reported on the basis of malfunction with potential for injury upon reoccurrence as the device piece was removed.

• 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: 12411039
• MDR Text Key: 270829208
• Report Number: 3007305485-2021-00364
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)230616(10)202006165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2021

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: 06/16/2023
• Device Model Number: IAS12-100LPI
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 202006165
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1