MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-01 for OLYMPUS A2637 83A2637 manufactured by Olympus Winter & Ibe Gmbh.
[19491195]
The customer returned an obturator because the tip of the obturator was locked in an angled position and would not straighten.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-1998-00012 |
| MDR Report Key | 175211 |
| Report Source | 05 |
| Date Received | 1998-07-01 |
| Date of Report | 1998-06-25 |
| Date of Event | 1998-06-02 |
| Date Mfgr Received | 1998-06-04 |
| Date Added to Maude | 1998-07-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-07-01 |
| Returned To Mfg | 1998-06-04 |
| Model Number | A2637 |
| Catalog Number | 83A2637 |
| Lot Number | 76W |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 170363 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | A2637 |
| Baseline Catalog No | 83A2637 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K931995 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-01 |