MAUDE Adverse Event Report: GYRUS ACMI, INC. VC10 PUMP, 115V; CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

Model Number	VC-10
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the during a hysterectomy procedure, the unit vc-10 pump was underperforming and not providing enough suction.Reportedly, the patient lost 2 liters of blood due to the issue which resulted in the procedure being prolonged.Details of the patient's current condition, procedural details and outcome of the procedure were requested but not available at the time of the report.
Event or Problem Description
Additional information received: the procedure was much longer than its scheduled time.It was completed with large amounts of blood lose.The device was inspected post procedure.The suction which should have been 71 cm hg was reading 62 cm hg occluded at the device inlet connector.The suction is back up to 68 cm hg.The staff refuses to use device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out e2, e3, and g2.Additionally, to provide information received through follow up b5 and to update field d9.The field service engineer inspected the vc-10 unit.It was discovered that the coupling body connector for the hose connection going into the fluid overflow trap assembly did not lock the coupling insert into the connector.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the reported event occurred due to the coupling body connector did not lock the coupling insert into the connector.However, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: VC10 PUMP, 115V
• Common Device Name: CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18708337
• Report Number: 3011050570-2024-00067
• Device Sequence Number: 15221451
• Product Code: HHK
• UDI-Device Identifier: 00821925010475
• UDI-Public: 00821925010475
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K030935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VC-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0078-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown