MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-20 for BERKELEY VACURETTE CANNULA, F-TIP 6MM 21665 manufactured by Acmi Circon.
[208764]
During a dialation and curettage the uterus was perforated. As the f-tip was being removed it was noticed that the f-tip broke and the tip of the f-tip was left in the pt. An ultrasound was performed immediately after surgery, but the f-tip could not be observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-2001-00003 |
| MDR Report Key | 343098 |
| Report Source | 05 |
| Date Received | 2001-07-20 |
| Date of Report | 2001-06-20 |
| Date of Event | 2001-06-11 |
| Date Mfgr Received | 2001-06-20 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2001-07-25 |
| 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 |
| Manufacturer Contact | BETH FREDERICKSON |
| Manufacturer Street | 3037 MT. PLEASANT ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626397205 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERKELEY VACURETTE CANNULA, F-TIP 6MM |
| Generic Name | FLEXIBLE TIP CURETTE |
| Product Code | HHK |
| Date Received | 2001-07-20 |
| Model Number | NA |
| Catalog Number | 21665 |
| Lot Number | FT00014 |
| ID Number | NA |
| 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 | 332434 |
| Manufacturer | ACMI CIRCON |
| 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 | 1. Required No Informationntervention | 2001-07-20 |