MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-20 for AIRSEAL 12MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP IAS12-100LPI manufactured by Sequel Special Products.
[181401311]
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.
Patient Sequence No: 1, Text Type: N, H10
[181401312]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2019-00452 |
| MDR Report Key | 9608264 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-20 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-01-20 |
| 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 | MS TRACEY WEISELBENTON |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 337734908 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734908 |
| Manufacturer Phone | 7273995557 |
| Manufacturer G1 | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Street | 122 AVENUE OF INDUSTRY PO BOX 11050 |
| Manufacturer City | WATERBURY CT 067035994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 067035994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRSEAL 12MM ACCESS PORT AND PALM GRIP OBTURATOR WITH BLADELESS OPTICAL TIP |
| Generic Name | INSUFFLATOR, LAPAROSCOPIC |
| Product Code | HIF |
| Date Received | 2020-01-20 |
| Returned To Mfg | 2020-01-15 |
| Catalog Number | IAS12-100LPI |
| Lot Number | 99419 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUEL SPECIAL PRODUCTS |
| Manufacturer Address | 122 AVENUE OF INDUSTRY PO BOX 11050 WATERBURY CT 06703 US 06703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-20 |