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

Model Number VC-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of reported event cannot be determined at this time.The vc-10 instruction manual warns users "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." as part of or investigation, olympus followed up with the user facility regarding the reported event and limited information was provided.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint.If additional information becomes available, this report will be updated and supplemented accordingly.

Event Description

Olympus was informed that the user facility performed 21 dilation and curettage (d&c) procedures between (b)(6) 2017 to present.Of that, four patients developed intrauterine hematomas and presented to the emergency room for treatment.In addition, patient 1 and patient 2 experienced heavy bleeding, patient 3 experienced pain with cramping and patient 4 developed a hematometrium.All four patients were managed under outpatient care.This is 4 of 4 reports.

• 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 ; 4089355124
• MDR Report Key: 8091946
• MDR Text Key: 128029685
• Report Number: 2951238-2018-00712
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC-10
• Device Catalogue Number: VC-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2018
• 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): Required Intervention