MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-03 for AIRSEAL 12/120MM LPI PORT IAS12-120LPI manufactured by Sequel Special Products.
[183305860]
The device is not being returned but photographic evidence was provided that confirmed the reported problem. A two-year lot history review could not be performed since a lot number was not provided. A review of the dhr could not be performed since a lot number was not provided. A two-year review of complaint history revealed there has been 10 complaints regarding 10 devices for this device family and failure mode. During the same time frame 837,046 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be. 00001. Per the instructions for use, the user is advised the following; use extreme caution during airseal access port insertion. Improper use of this product can result in life-threatening injury to internal organs and vessels. Ensure the adequate pneumoperitoneum or pneumorectum is established; ensure that the patient is properly positions so that organs are away from the penetration site; direct the airseal access port's tip away from significant vessels and organs; do not use excessive downward force; once a safe and proper entry has been achieved, ensure that the black line at the distal tip of the airseal access port is visible within the cavity at all times the airseal access port is being used for insufflation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[183305861]
The conmed representative reported on behalf of the facility that the ias12-120lpi, airseal 12/120mm port's outer lumen tip broke off during a robotic nephrectomy on (b)(6) 2020. The defect was not noticed until the end of the surgery, another port was used to complete the procedure. The port and the cracked piece were accounted for. There was no patient injury or impact. There was a 5-minute delay to get another port. The team was familiar with the device and the defect did not signal a problem. This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00018 |
| MDR Report Key | 9660231 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO, FL FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Street | 1 HILLSIDE DR |
| Manufacturer City | WOLCOTT, CT CT 06716 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRSEAL 12/120MM LPI PORT |
| Generic Name | AIRSEAL TROCAR |
| Product Code | HIF |
| Date Received | 2020-02-03 |
| Catalog Number | IAS12-120LPI |
| Lot Number | 119819 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Address | 1 HILLSIDE DR WOLCOTT CT 06716 US 06716 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |