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 BERKELEY VACURETTE F-TIP 6MM 21665 manufactured by Circon Surgitek.
[123573]
The f-tip vacurette broke during a vacujm curretage procedure that was performed after the pt had a missed abortion. Due to fibroids of the uterus, the dr had trouble guiding the f-tip vacurette into the uterus and the f-tip possibly went up a blind path. When trying to remove the f-tip, it became stuck. Force was used to remove the f-tip vacurette and the tip broke off. It could not be determined if the tip remained inside the pt. An ultrasound and a hysteroscopy were performed to locate the tip. Neither procedure showed signs of the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-1998-00001 |
| MDR Report Key | 158414 |
| Report Source | 05 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-02-19 |
| Date of Event | 1998-02-16 |
| Date Mfgr Received | 1998-02-19 |
| Device Manufacturer Date | 1991-05-01 |
| Date Added to Maude | 1998-03-25 |
| 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 | BERKELEY VACURETTE F-TIP 6MM |
| Generic Name | FLEXIBLE TIP CURETTE |
| Product Code | HHK |
| Date Received | 1998-03-17 |
| Model Number | NA |
| Catalog Number | 21665 |
| Lot Number | 1E2222 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 154312 |
| Manufacturer | CIRCON SURGITEK |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACURETTE CANNULA, F-TIP |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 21665 |
| Baseline ID | F-TIP VACURETTE |
| Baseline Device Family | F-TIP VACURETTE |
| 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 | 1998-03-17 |