MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-04-24 for OLYMPUS A2636 83A2636 manufactured by Olympus Winter & Ibe Gmbh.
[85844]
The customer returned an obturator to co's repair facility, because the tip would not angulate. The obturator was locked in position. On march 4, 1998 the obturator locked in position during preparation, prior to the procedure to be performed. A second device was used to perform the procedure and no problems were encountered. The customer would not release any info regarding the procedure being performed, since the failed device was not used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[7763504]
Upon eval, the mfr found that the epoxy cement used to secure an internal screw in the deflecting tip of the obturator had deteriorated over time. This allowed the screw to shift, and as a result, the obturator locked in a deflected position. To counter this phenomenon, the mfr has validated a change to a laser welding process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-1998-00008 |
| MDR Report Key | 164784 |
| Report Source | 05 |
| Date Received | 1998-04-24 |
| Date of Report | 1998-04-06 |
| Date of Event | 1998-03-04 |
| Date Mfgr Received | 1998-03-20 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1998-04-29 |
| 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 | 1998-04-24 |
| Returned To Mfg | 1998-03-23 |
| 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 | 160393 |
| 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 | 1998-04-24 |