MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-10-13 for JONES IMA DIAMOND KNIFE 80-1860 manufactured by Johnson & Johnson Professional, Inc..
[21588501]
Per phone converstion with customer svc, the instrument broke and the tip fell in the pt, and was not retrieved. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1998-00180 |
| MDR Report Key | 191460 |
| Report Source | 05 |
| Date Received | 1998-10-13 |
| Date of Report | 1998-10-13 |
| Date Mfgr Received | 1998-09-21 |
| Date Added to Maude | 1998-10-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JONES IMA DIAMOND KNIFE |
| Generic Name | SURGICAL INSTRUMENT, MANUAL |
| Product Code | EMF |
| Date Received | 1998-10-13 |
| Model Number | NA |
| Catalog Number | 80-1860 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 186045 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 027670350 US |
| Baseline Brand Name | JONES IMA DIAMOND KNIFE |
| Baseline Generic Name | SURGICAL INSTRUMENT, MANUAL |
| Baseline Model No | NA |
| Baseline Catalog No | 80-1860 |
| Baseline ID | NA |
| Baseline Device Family | JONES DIAMOND KNIFE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-13 |