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

Model Number VC-10

Device Problem Suction Problem (2170)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, during a therapeutic dilatation and curettage with suction procedure for a pregnancy at 10 weeks, the subject device suctioned more than it should have during the procedure and the patient had a blood loss of 500 mls.The physician turned on the suction and heard 3 loud sounds.The customer stated the noise could have been canisters rattling in the machine because they are smaller.The physician noted the bleeding occurred toward the beginning of the procedure after the first sharp curetting.No intervention or treatment was provided due to the blood loss and the patient was discharged.The patient's pre-operative and post-operative blood pressure ranged 119/73- 121/76.The patients pre-operative hemoglobin was 12.5 and hematocrit was 39.6.No post-operative labs were taken.The patient did not experience signs and symptoms of blood loss post-operatively and did not received a blood transfusion post-operatively.The device was inspected prior to the procedure and it appeared to be in working order per the customer.The intended procedure was completed with the same device.There was no delay in the procedure.The customer stated they were unable to get replacement cannisters and are using bemis brand cannisters which are smaller.The bemis cannister used was 500ml in size with a size 10 suction curette and berkley tubing.The subject device settings were at 64cm hg during the procedure.The customer stated the subject device was in green zone during the entire procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.This unit was produced in august 2011.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The provided dhrs do not include packaging or labeling operations.For this reason, a final manufacture date is not available.Based on the results of the investigation, a probable cause of the reported event is due to the use of incorrect collection canisters.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu).The ifu states "the use of applied parts, accessories, and cables other than those specified by the manufacturer for which the system was designed could result in increased electromagnetic missions or decreased electromagnetic immunity of this equipment and result in improper operation" (page 3); "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" (page 4).Olympus will continue to monitor the field performance of this device.

• Brand Name: VC10 PUMP, 115V
• Type of Device: PUMP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 13723810
• MDR Text Key: 294804590
• Report Number: 3003790304-2022-00036
• Device Sequence Number: 1
• Product Code: HHI
• UDI-Device Identifier: 00821925010475
• UDI-Public: 00821925010475
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Hispanic