MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-28 for SEECLEAR XCL * SC082500 manufactured by Coopersurgical, Inc..
[4323976]
Robotic-assisted total laparoscopic hysterectomy with robotic assisted and bilateral salpingo-oophorectomy, cystoscopy. During the procedure the smoke evacuation tubing had sub-optimal smoke evacuation, delaying the procedure until smoke cleared from the abdominal cavity. Per staff, "it took a long time and the product does not work well". Unsure of exact amount of time. We have had repeated issues with the product according to our staff. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3732816 |
| MDR Report Key | 3732816 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-03 |
| Report Date | 2014-03-28 |
| Date Reported to FDA | 2014-03-28 |
| Date Reported to Mfgr | 2014-04-08 |
| Date Added to Maude | 2014-04-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEECLEAR XCL |
| Generic Name | TUBE, SMOKE REMOVAL, ENDOSCOPIC |
| Product Code | FCZ |
| Date Received | 2014-03-28 |
| Model Number | * |
| Catalog Number | SC082500 |
| Lot Number | 147344 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-28 |