MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-26 for HYSTEROSCOPIC BIOPSY FORCEP 8992.63 manufactured by Richard Wolf Gmbh.
[19548829]
An operative hysteroscopy procedure was in progress when a "screw" from the biopsy forceps came loose in the uterus and was seen on the video screen. Suction d&c of the uterus was done but the small piece (1mm diameter) was not found visually or on x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 165985 |
| MDR Report Key | 165985 |
| Date Received | 1998-04-26 |
| Date of Report | 1998-03-27 |
| Date of Event | 1998-03-11 |
| Date Facility Aware | 1998-03-11 |
| Report Date | 1998-03-12 |
| Date Reported to Mfgr | 1998-03-12 |
| Date Added to Maude | 1998-05-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSTEROSCOPIC BIOPSY FORCEP |
| Generic Name | HYSTEROSCOPIC BIOPSY FORCEP |
| Product Code | HFB |
| Date Received | 1998-04-26 |
| Model Number | 8992.63 |
| Catalog Number | 8992.63 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 161532 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | HYSTEROSCOPIC BIOPSY FORCEPS |
| Baseline Generic Name | HYSTEROSCOPIC BIOPSY FORCEPS |
| Baseline Model No | 8992.63 |
| Baseline Catalog No | 8992.63 |
| Baseline ID | UNK |
| Baseline Device Family | BIOPSY FORCEPS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-26 |