MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-10-27 for OLYMPUS A5578 NA manufactured by Olympus Winter & Ibe Gmbh.
[169270]
A hosp bio-medical technician (bmt) reported that the tip of a reusable a5578 spatula electrode separated from the instrument shaft and fell into the pt's chest cavity during a thoroscopy procedure. The surgeon retrieved the piece and the procedure was completed without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2000-00038 |
| MDR Report Key | 302864 |
| Report Source | 07 |
| Date Received | 2000-10-27 |
| Date of Report | 2000-09-28 |
| Date Mfgr Received | 2000-09-28 |
| Date Added to Maude | 2000-11-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2 CORPORATE CENTER DR |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6318445688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | SPATULA ELECTRODE |
| Product Code | EWY |
| Date Received | 2000-10-27 |
| Model Number | A5578 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 293143 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | SPATULA ELECTRODE |
| Baseline Model No | A5578 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K912362 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-27 |