MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-11-13 for BERKELEY VACURETTE CANNULA, F-TIP 21745 manufactured by Circon Surgitek.
[137088]
During a dilation and curettage, the uterus was perforated. During the attempt to extract the f-tip from the uterus, the tip of the f-tip was caught on the uterus and broke off when pulled. A mini-laparotomy was performed to repair the penetration and retrieve the broken portion of the f-tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-1999-00012 |
| MDR Report Key | 249903 |
| Report Source | 05 |
| Date Received | 1999-11-13 |
| Date of Report | 1999-11-12 |
| Date of Event | 1999-10-08 |
| Date Mfgr Received | 1999-10-14 |
| Device Manufacturer Date | 1998-01-01 |
| Date Added to Maude | 1999-11-17 |
| 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 | CAROLYN DE JONGE |
| Manufacturer Street | 609 BEECHWOOD RD |
| Manufacturer City | WILLOW GROVE PA 19090 |
| Manufacturer Country | US |
| Manufacturer Postal | 19090 |
| Manufacturer Phone | 2156581655 |
| 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 |
| Generic Name | FLEXIBLE TIP CURETTE |
| Product Code | HHK |
| Date Received | 1999-11-13 |
| Model Number | NA |
| Catalog Number | 21745 |
| Lot Number | 5V0202 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 242111 |
| Manufacturer | CIRCON SURGITEK |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACURETTES, F-TIP, 8 MM |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | * |
| Baseline Catalog No | 21745 |
| Baseline ID | * |
| 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 | 1999-11-13 |