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 2020-03-31 for AISEAL 12/120MM LPI PORT IAS12-120LPI manufactured by Sequel Special Products.
[187570589]
The reported device is expected to be 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.
Patient Sequence No: 1, Text Type: N, H10
[187570590]
The conmed representative reported on behalf of the facility that the ias12/120lpi, airseal 12mm port's sound cap fell into a patient on (b)(6) 2020 during a partial nephrectomy. The sound cap was noticed missing mid procedure. It was removed using a grasper. It is not known what instrument or product was used at the time the seal was pushed in, but it is not unusual for the surgeons to use a lap sponge during that part of the procedure. There was no reported surgical delay. There was no reported patient injury or impact. This report is being raised due to device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00159 |
| MDR Report Key | 9904082 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3995209 |
| Manufacturer G1 | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Street | 1 HILLSIDE DR |
| Manufacturer City | WOLCOTT, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AISEAL 12/120MM LPI PORT |
| Generic Name | LAPAROSCOPIC TROCAR/PORT |
| Product Code | HIF |
| Date Received | 2020-03-31 |
| Catalog Number | IAS12-120LPI |
| Lot Number | 87919 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |