MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 12MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS12-100LPI

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been returned to conmed 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

This record captures the issue with the ias12-100lpi, airseal 12mm access port and palm grip obturator with bladeless optical tip, 100mm length, lot 99419 as reported by the facility to conmed (b)(4).It is reported that on (b)(6) 2019, during a "ralp" procedure the trocar cap rubber valve broke, and the fragment fell into the abdominal cavity.The fragments have been collected immediately.It is indicated that the procedure was successfully completed.Additional information received confirmed the procedure was a robot-assisted laparoscopic prostatectomy.While the surgeon was manually operating surgical instruments through the trocar, the rubber valve fell off in 1 piece into the patient.The piece was retrieved through the trocar by using forceps.It was confirmed that there was no impact or injury to the patient and the procedure was completed as scheduled & planned.This report is being raised on the basis of previous us fda mdr reporting of similar malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

H11: the report is being submitted to correct the following fields: g2, h10.H10 - the h10 narrative should read "although not verified, a 2 year lot history review conducted on the reported lot found this is the only event for this lot number.The device is manufactured by sequel special product; a dhr review request was made for the reported lot however, no review has been received to date.As the dhr review was not received from the vendor, the date of manufacture cannot be determined.H10 was originally reported as " although a lot number was provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record (dhr) as the device is manufactured by sequel special products.Although requested, dhr information was not provided and a date of manufacture could not be determined." the other information remains unchanged and correct.

Manufacturer Narrative

The reported event of the trocar cap rubber valve breaking off is confirmed.Conmed received one ias12-100lpi in unoriginal packaging.The lot number was not verified as the device lot number was not listed on the device.A visual inspection was performed and confirmed piece of the rubber seal was torn off the sound cap.Although a lot number was provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record (dhr) as the device is manufactured by sequel special products.Although requested, dhr information was not provided and a date of manufacture could not be determined.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 0.00002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is also advised that failure to properly follow the instructions for use can lead to serious surgical consequences.The ifu also advises the user that if using the sound cap, inspect the 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.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; po box 11050; waterbury CT 06703
• MDR Report Key: 9608264
• MDR Text Key: 181401311
• Report Number: 1320894-2019-00452
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 99419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1