MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for PUREVIEW * 0620-030-100 manufactured by Stryker Endoscopy.
[6436953]
During a robotic procedure, the circulator stated the surgeon wasn't happy with the way the gas was being evacuated out of the patient so they took two of these smoke evac devices and hooked it up to two different trocars. During the use of this device the circulator went to change the gas tank and this device sucked out all the gas inside the patient, leaving the robotic instruments and light source to the scope on which could potentially harm the patient. As the stomach was deflated, there was a concern if the patient could have been burned due to inability to see inside the patient when stomach was deflated too quickly by the device. The representative of the company was notified about the use of this new product as there was not a proper in service on the use of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4931214 |
| MDR Report Key | 4931214 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-07-02 |
| Report Date | 2015-07-06 |
| Date Reported to FDA | 2015-07-06 |
| Date Reported to Mfgr | 2015-07-22 |
| Date Added to Maude | 2015-07-22 |
| 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 | 3 |
| 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 | PUREVIEW |
| Generic Name | TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC |
| Product Code | NKC |
| Date Received | 2015-07-06 |
| Model Number | * |
| Catalog Number | 0620-030-100 |
| Lot Number | 15A31N |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |