MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-23 for BERKLEY VACUUM CURETTAGE SYSTEM VC2-115VAC60HZ NA manufactured by Cabot Medical Corp..
[161821]
Dilation and evacuation machine was noted to have less suction than usual during a procedure. The pt underwent an ultrasound which showed a small amount of tissue remaining. The machine was checked, and it was discovered that the plastic filter housing was cracked resulting in less suction. This was replaced and vacuum was verified to 68 cm of mercury. The pt returned the following day for a repeat procedure. A small amount of tissue was suctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 251744 |
| MDR Report Key | 251744 |
| Date Received | 1999-11-23 |
| Date of Report | 1999-10-07 |
| Date of Event | 1999-09-21 |
| Date Facility Aware | 1999-09-21 |
| Report Date | 1999-10-07 |
| Date Reported to Mfgr | 1999-10-07 |
| Date Added to Maude | 1999-12-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BERKLEY VACUUM CURETTAGE SYSTEM |
| Generic Name | DILATION AND EVACUATION MACHINE |
| Product Code | HGG |
| Date Received | 1999-11-23 |
| Model Number | VC2-115VAC60HZ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243821 |
| Manufacturer | CABOT MEDICAL CORP. |
| Manufacturer Address | 2021 CABOT BLVD WEST. LANGHORNE PA 19047 US |
| Baseline Brand Name | BERKLEY VACUUM CURETTAGE SYSTEM |
| Baseline Generic Name | DILATION AND EVACUATION MACHINE |
| Baseline Model No | VC2-115VAC60HZ |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-11-23 |