MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS AIRSEAL 12/100MM LPI PORT; INSUFFLATOR, LAPAROSCOPIC

Catalog Number IAS12-100LPI

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The reported device is being 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

The customer reported that ias12-100lpi device was being used on (b)(6) 2019 during a vats surgery.The doctor stated that he was close to the end of the surgery, after collecting the specimen, that he noticed a crack in the device.The missing fragment was found on the cover cloth which was outside the patient's body.The fragment did not come into contact with the patient.The doctor stated "when extracting the trocar and putting it into the pocket on the cover cloth, he put several equipment on top of each other in the pocket too.Perhaps it caused the crack." this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one ias12-100lpi in opened original packaging.Lot number could not be verified.Performed a visual inspection, the distal tip of the device is broken.It appears the device may have undergone excessive pressure.The manufacturing documents from the device history record have not been reviewed due to the lot number being unknown.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: precautions: use extreme caution during airseal access port insertion.Improper use of this product can results in life-threatening injury to internal organs and vessels.Do not use excessive downward force.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: AIRSEAL 12/100MM LPI PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr; wolcott CT 06716
• MDR Report Key: 9375048
• MDR Text Key: 181398576
• Report Number: 1320894-2019-00405
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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 Catalogue Number: IAS12-100LPI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/10/2020
• Patient Sequence Number: 1