MAUDE Adverse Event Report: BERKELEY MEDEVICES VACURETTE CURVED 8MM 10/PKG; VACUUM CURETTAGE SYSTEM

Model Number 20317

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a user medwatch reporting a tip of a vacurette cannula that was broken off and missing.The nurse observed the broken curette after completion of a therapeutic dilation and curettage for a delayed miscarriage.The packaging which contained the device was inspected and broken items of the vacurette cannula was observed.The surgeon was notified and a uterine ultrasound of the patient was performed to look for any device fragments.None were reported to be found.No further information was provided.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer for mdr# 2951238-2020-00352.No device was returned; therefore, a physical evaluation of the could not be performed.Additionally, the device history records could not be obtained by the original equipment manufacturer.An investigation was completed by the legal manufacturer, however, based on limited information a root cause of the reported complaint cannot be determined at this time.Olympus will continue to monitor the field performance of this device.

• Brand Name: VACURETTE CURVED 8MM 10/PKG
• Type of Device: VACUUM CURETTAGE SYSTEM
• Manufacturer (Section D): BERKELEY MEDEVICES; 1330 south 51st street; richmond CA 94804 4628
• MDR Report Key: 9786213
• MDR Text Key: 200617508
• Report Number: 2951238-2020-00352
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• PMA/PMN Number: K030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 20317
• Device Lot Number: 02194485
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1