MAUDE Adverse Event Report: GYRUS ACMI, INC. VC10 PUMP, 115V; ABORTION SUCTION SYSTEM COLLECTION BOTTLE

Model Number	VC-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Uterine Perforation (2121); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, two patient events involving the vc10 pump and non-olympus canisters due to the olympus berkeley safetouch collection system canister back-order.The facility used a larger canister with inadequate suction with two different patients.Patient one (1), reported with patient identifier (b)(6), had a cesarean section on (b)(6) 2022 and returned to the facility five (5) weeks later on (b)(6) 2022 with uncontrolled bleeding from retained products of conception.The patient had a dilation and curettage , a blood transfusion, and perforation which resulted in a hysterectomy.The patient was admitted to the icu.Patient two (2), reported with patient identifier (b)(6), had a miscarriage and had a dilation and curettage on (b)(6) 2022.She returned to the emergency department (b)(6) 2022 for heavy vaginal bleeding associated with retained products of conception.The patient was required to have a second dilation and curettage procedure (b)(6) 2022 and was sent home on medications to keep her uterus contracted to prevent future bleeding.The facility reported both patients are recovering.(b)(6) is for patient 1, (b)(6) is for patient 2.This is report 1 of 2 for (b)(6) for patient 1.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, there is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: VC10 PUMP, 115V
• Common Device Name: ABORTION SUCTION SYSTEM COLLECTION BOTTLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15175717
• Report Number: 1519132-2022-00015
• Device Sequence Number: 17724618
• Product Code: HHI
• UDI-Device Identifier: 00821925010475
• UDI-Public: 00821925010475
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/16/2022
• 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: NON-OLYMPUS CANNISTER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female