MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-03 for 06396500001 760-700 manufactured by Ventana Medical Systems Inc.
[113049369]
Sticking and leaking dispensers required repeat runs. The repeat runs exhausted the patient tissue sample and required a re-biopsy. This is the initial and final report.
Patient Sequence No: 1, Text Type: N, H10
[113049370]
Failed runs due to sticking or leaky dispensers required repeating the runs and led to tissue sample of patient being exhausted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2018-00011 |
| MDR Report Key | 7658942 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-07-03 |
| 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 | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | OPTIVIEW DAB |
| Product Code | NJT |
| Date Received | 2018-07-03 |
| Model Number | 06396500001 |
| Catalog Number | 760-700 |
| Lot Number | E00712 |
| ID Number | NA |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-03 |