MAUDE Adverse Event Report: GYRUS ACMI, INC VC10 PUMP, 115V

Model Number VC-10

Device Problem Increase in Suction (1604)

Patient Problem Blood Loss (2597)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determine; however, based on the reported event user error cannot be ruled out as a contributory factor.The instruction manual provides the user several warnings to mitigate patient injury.¿study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.The sliding ring on the handle may be used to control the vacuum.If the cannula adheres to the uterine wall or becomes clogged, release the suction by moving the sliding ring from the closed position to the open position to decrease the vacuum prior to removal of the cannula.For foot pedal operation, confirm that the foot pedal is properly attached.Do not apply excessive force while using the cannulas and f-sets.Excessive pushing, bending, or pulling could result in injury to the patient and/or breakage of the device.¿.

Event Description

The user facility informed olympus that during a suction dilation and evacuation (d&e procedure, the end user released the footswitch but the vc-10 suction did not stop and the pressure increased resulting in the patient sustaining blood loss.The patient was administered multiple blood transfusions.The intended procedure was completed with a similar device.The patient was admitted to the hospital.In addition, the user facility¿s team lead reported that it is believed that the tubing to the suction was set up improperly and attributed to the reported event.The end user inspected the fluid overflow protection/safety trap collection system post procedure and found that both canisters were full of fluid & tissue.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).The oem performed a review of the device history record (dhr) and found no anomalies during the manufacturing of the subject device and serial number.

• Brand Name: VC10 PUMP, 115V
• Type of Device: VC10 PUMP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7153069
• MDR Text Key: 96004859
• Report Number: 2951238-2017-00791
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VC-10
• Device Catalogue Number: VC-10
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention