MAUDE Adverse Event Report: GYRUS ACMI, INC VC10 PUMP, 115V; SYSTEM, ABORTION, VACUUM

Model Number	VC-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during a dilation and evacuation (d+e) procedure using a vc-10 pump, the patient lost 1.6 liters of blood.Sequences of events as follows: the patient was scheduled for a d+e procedure at 15 weeks gestation for fetal anomaly.The patient was non-adherent with the cervical preparation.The cervix was challenging to dilate due to lack of prep and patient anatomy.The physician was able to dilate the cervix to 13.A size 13 curette was not available.The physician was unable dilate the cervix to 14 to use the available curette.Surgical assistance was called.The physician was able to complete the procedure through other (unspecified) techniques.The lack of equipment caused prolongation of the case and ongoing bleeding.The estimated blood loss (ebl) was 1.6l total.The patient was able to be discharged home from the post anesthesia care unit (pacu) without transfusion.No additional consequences to the patient have been reported.There is no report of vc-10 malfunction.Additional information regarding the patient and reported event have been requested.At this time, no additional information has been provided.
Event or Problem Description
Additional information provided by the customer: the source of bleeding was two cervical lacerations due to the difficulty with dilation.The bleeding was treated with sutures and administration of methergine x1.The patient's current condition is stable, discharged with no further bleeding.The vc-10 did not cause or contribute to the prolongation of the procedure or bleeding, this was caused by anatomical complications and lack of prep.The serial number of the vc-10 cannot be provided.The vc-10 did not malfunction in any way.
Additional Manufacturer Narrative
This report is being updated to provide additional information reported by the customer (b)(6) 2021.New information is reported in a2, a4, and b5.

• Brand Name: VC10 PUMP, 115V
• Common Device Name: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 12679112
• Report Number: 1519132-2021-00018
• Device Sequence Number: 3707057
• Product Code: HHI
• UDI-Device Identifier: 00821925010475
• UDI-Public: 00821925010475
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: VC-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIZE 14 CURETTE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 75 KG