MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for VITAL VUE 8886828426 manufactured by Plexus Corp.
[119536666]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119536667]
According to the reporter, during laparoscopic urology, the disposable did not work properly so the customer requested to check the body part. A spark came out from the tip of the product. The procedure was completed with another device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2018-00840 |
| MDR Report Key | 7852838 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-09-06 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | PLEXUS CORP |
| Manufacturer Street | 120 MAIN ST |
| Manufacturer City | NEENAH WI 549563768 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 549563768 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITAL VUE |
| Generic Name | ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD |
| Product Code | HBI |
| Date Received | 2018-09-06 |
| Model Number | 8886828426 |
| Catalog Number | 8886828426 |
| Lot Number | U0812375 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS CORP |
| Manufacturer Address | 120 MAIN ST NEENAH WI 549563768 US 549563768 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |