MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-08-21 for MYOMA SCREW 8383.611 manufactured by Richard Wolf Medical Instruments Corp..
[20137352]
During a gynecologic laparoscopy procedure to remove a myoma,the helical tip of the myoma screw came off while it was in the myoma. The tip was retrieved with no consequences for the pt. The device was sent to the mfr for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1997-00041 |
| MDR Report Key | 115233 |
| Report Source | 00 |
| Date Received | 1997-08-21 |
| Date of Report | 1997-07-22 |
| Date of Event | 1997-07-21 |
| Date Facility Aware | 1997-07-21 |
| Report Date | 1997-07-22 |
| Date Reported to Mfgr | 1997-07-22 |
| Date Mfgr Received | 1997-07-22 |
| Device Manufacturer Date | 1993-04-01 |
| Date Added to Maude | 1997-08-27 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOMA SCREW |
| Generic Name | MYOMA SCREW |
| Product Code | HHO |
| Date Received | 1997-08-21 |
| Returned To Mfg | 1997-07-22 |
| Model Number | 8383.611 |
| Catalog Number | 8383.611 |
| Lot Number | 4D3 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4.3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 113100 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US |
| Baseline Brand Name | MYOMA SCREW |
| Baseline Generic Name | MYOMA SCREW |
| Baseline Model No | 8383.611 |
| Baseline Catalog No | 8383.611 |
| Baseline ID | 4D3 |
| Baseline Device Family | MYOMA SCREW |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940844 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-21 |