BERKELEY VACUUM CURETTAGE SYSTEM VC-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for BERKELEY VACUUM CURETTAGE SYSTEM VC-10 manufactured by Berkeley Medevices.

Event Text Entries

[49426112] Sealing caps that are a part of this kit do not fit snugly, they are as we are told designed to sit on top the canister until suction is applied. This design allows the caps to fall off the unit if moved or shifted. The kit comes with one cap and if it falls to the floor another entire kit must be opened. If attempts to secure the cap to the canister is applied the cap cracks thus losing sufficient suction to perform the procedure. The design of the cap attachment to the canisters should be evaluated for a better and safer design for efficiency, cost effectiveness as well as proper use of the equipment. Reason for use: uterine dilatations and curettages.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063330
• MDR Report Key: 5784862
• Date Received: 2016-07-07
• Date of Report: 2016-07-07
• Date of Event: 2016-06-17
• Date Added to Maude: 2016-07-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: BERKELEY VACUUM CURETTAGE SYSTEM
• Generic Name: BERKELEY VACUUM CURETTAGE SYSTEM
• Product Code: HHI
• Date Received: 2016-07-07
• Model Number: VC-10
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BERKELEY MEDEVICES

Device Sequence Number: 2

• Brand Name: BERKELEY SAFETOUCH TISSUE TRAP
• Generic Name: BERKELEY SAFETOUCH TISSUE TRAP
• Product Code: HHK
• Date Received: 2016-07-07
• ID Number: 003853-902
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GYRUS ACMI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-07