MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-13 for NEOPROBE MACHINE CU 1598520 * manufactured by Ethicon Inc. Johnson & Johnson.
[256634]
Add'l info rec'd from mfr 10/22/02: mfr has become aware of an event which involves a device not manufactured by ethicon. In support of the smda they are forwarding this info to fda office. The following info was reported to mfr by the user facility. The neoprobe probe and cord were hooked up to the neoprobe machine. No numbers registered and no sound was emitted when placed near the incision. The probe and collimator were changed with no results. In house biomedical engineer tech was called and tech support from ethicon was called and the rep will come to the hospital to evaluate the unit. No ethicon device was involved in this event. This device is not manufactured by ethicon. The date of the event is unknown, however the report was issued on 08/06/2002. This info was reported via voluntary medwatch to an ethicon rep.
Patient Sequence No: 1, Text Type: D, B5
[256999]
Add'l info rec'd from mfr 10/22/02: mfr has become aware of an event which involves a device not mfg by ethicon. In support of the smda they are forwarding this info to fda office. The following info was reported to mfr by the user facility: the neoprobe probe and cord were hooked up to the neoprobe machine. No numbers registered and no sound was emitted when placed near the incision. The probe and collimator were changed with no results. In house biomedical engineer tech was called and tech support from ethicon was called and the rep will come to the hosp to evaluate the unit. No ethicon devive was involved in this event. This device is not mfg by ethicon. The date of the event is unk, however the report was issued on 8/6/02. This info was reported via voluntary medwatch to an ethicon rep.
Patient Sequence No: 1, Text Type: D, B5
[261022]
The neoprobe probe and cord were hooked up to the neoprobe machine. No numbers registered and no sound was emitted when placed near the incision. The probe and collimator were changed with no results. In house biomedical engineer tech was called and tech support from ethicon was called and the rep will come to hosp to evaluate the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025815 |
| MDR Report Key | 410485 |
| Date Received | 2002-08-13 |
| Date of Report | 2002-08-06 |
| Date of Event | 2002-07-29 |
| Date Added to Maude | 2002-08-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOPROBE MACHINE |
| Generic Name | NEOPROBE |
| Product Code | IZD |
| Date Received | 2002-08-13 |
| Model Number | CU 1598520 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 399494 |
| Manufacturer | ETHICON INC. JOHNSON & JOHNSON |
| Manufacturer Address | US RT 22 W PO BOX 151 SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-13 |