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

Catalog Number IASB12-100

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2020

Event Type  Injury  

Event Description

Update: conmed (b)(6) reported on 21nov21 that they would be filing this complaint to the pmda; therefore, a medwatch report will be filed in conjunction with all ous adverse events.It was reported by conmed (b)(6) on behalf of their customer that during a laparoscopic pancreatectomy surgery on (b)(6) 2020 the isab12-100 airseal 12/100mm blunt port had a broken spring anchor.An alternate iasb12-100 was used to complete the surgery.There was no patient or user injury reported.There was no delay to the procedure.After further assessment it was found, it is unknown if the fragments of the port made contact with the patient.This report is being raised on the basis of injury due to unknown whereabouts of the device fragments.

Manufacturer Narrative

Additional fda product code: gcj reported event is confirmed.Customer event ¿spring anchor, a component of the iasb12-100, was broken.¿ was confirmed based on photographic evidence and device evaluation.Received one iasb12-100 opened in unoriginal packaging.Lot number not verified.Performed visual inspection on device, the spring anchor assembly on the cannula is cracked and broken on the end of the device.A two-year lot history review cannot be conducted as no lot number was provided.A device history review cannot not be conducted as no lot number was provided.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 22 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).Per the instructions for use, the user is advised the following: failure to properly follow the instructions for use can lead to serious surgical consequences.Use extreme caution during airseal access port insertion.Improper use of this product can result 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 BLUNT PORT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside drive; wolcott CT 06716
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 1 hillside drive; wolcott CT 06716
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13017559
• MDR Text Key: 282325238
• Report Number: 1320894-2021-00447
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IASB12-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic