MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for LAPAROVUE 132393 manufactured by Buffalo Filter, Llc.
[106449259]
Patient Sequence No: 1, Text Type: N, H10
[106449260]
The lapvue swab device was being used to clean the davinci xi robotic trocar and the swab part of the device broke off before being successfully removed. The swab landed on the abdominal cavity of the patient. It was located by the surgeon, and was removed prior to surgical completion. No harm was done to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7457606 |
| MDR Report Key | 7457606 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-02-09 |
| Report Date | 2018-04-23 |
| Date Reported to FDA | 2018-04-23 |
| Date Reported to Mfgr | 2018-04-23 |
| Date Added to Maude | 2018-04-25 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAPAROVUE |
| Generic Name | ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY |
| Product Code | OCT |
| Date Received | 2018-04-25 |
| Model Number | 132393 |
| Lot Number | 135125 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUFFALO FILTER, LLC |
| Manufacturer Address | 5900 GENESEE STREET LANCASTER NY 14086 US 14086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |