MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-03-17 for OLYMPUS A2636 83A2636 manufactured by Olympus Winter & Ibe Gmbh.
[107170]
While setting up for the procedure, the urodynamic technician pushed on the back portion of the obturator to straighten it out, but the obturator could not be straightened since it had locked in the bent position. Although the technicain soaked the device in nutra-ph instrument milk bath, the obturator could not be released.
Patient Sequence No: 1, Text Type: D, B5
[7830721]
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 | 9610773-1998-00005 |
| MDR Report Key | 157976 |
| Report Source | 05 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-02-17 |
| Date Mfgr Received | 1998-02-17 |
| Date Added to Maude | 1998-03-23 |
| 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 | OLYMPUS |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 1998-03-17 |
| Model Number | A2636 |
| Catalog Number | 83A2636 |
| Lot Number | 74W |
| 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 | 153912 |
| 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 | 1998-03-17 |