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 A2636 83A2636 manufactured by Olympus Winter & Ibe Gmbh.
[19166008]
The customer returned an obturator and sheath because the tip of the obturator was locked and would not angulate. The obturator locked while in the sheath. The physician attempted to remove the locked obturator from the sheath and this caused the ceramic break of the sheath to crack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-1998-00011 |
| MDR Report Key | 175206 |
| Report Source | 05 |
| Date Received | 1998-07-01 |
| Date of Report | 1998-06-25 |
| Date of Event | 1998-05-19 |
| Date Mfgr Received | 1998-05-26 |
| 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 | 1998-05-26 |
| Model Number | A2636 |
| Catalog Number | 83A2636 |
| Lot Number | NA |
| 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 | 170358 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG GM 22045 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | OBTURATOR |
| Baseline Model No | A2636 |
| Baseline Catalog No | 83A2636 |
| 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 |