MAUDE Adverse Event Report: GYRUS ACMI, INC. VACURETTE CANNULA; SYSTEM, ABORTION, VACUUM

Model Number 20317

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Pt was undergoing a d&c for missed ab.Disposable curette opened to field for suction d&c machine.After using the curette, i noticed the tip of curette was broken.The package was checked and pieces of the curette were found in the package.Surgeon was notified.Surgeon repeated a uterine ultrasound and felt uncomfortable that no pieces of the curette were present in the uterus.Fda safety report id# (b)(4).

• Brand Name: VACURETTE CANNULA
• Type of Device: SYSTEM, ABORTION, VACUUM
• Manufacturer (Section D): GYRUS ACMI, INC.
• MDR Report Key: 9622291
• MDR Text Key: 176556334
• Report Number: MW5092448
• Device Sequence Number: 1
• Product Code: HHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 20317
• Device Lot Number: 02194485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR