MAUDE Adverse Event Report: COOPERSURGICAL, INC. UTERINE EXPLORA CURETTE - MODEL I; 3MM OD CURETTE WITH VACU-LOK SYRINGE

Model Number	MX120
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by the user facility via medwatch: on [redacted] 2024, the patient was in the office and had a sis procedure to evaluate post-menopausal bleeding.The patient underwent a pelvic sonogram and a uterine biopsy.No complications were noted.On [redacted] 2025, the patient sent a message to the office that she had a yellow plastic clip come out of her vagina while in the shower following intercourse.She had reported that her husband mentioned feeling a hard object inside of her vagina with intercourse previously.The patient was seen in the office for her annual evaluation to evaluate further, it does not appear there was significant injury.The patient was diagnosed with bacterial vaginitis at the follow up appointment and treated with doxycycline.Mx120 uterine explora (b)(4).
Additional Manufacturer Narrative
Distribution history: the lot number was not provided, so a manufacture date, dhr number and ship date are not available.Manufacturing record review: a review of the device history record could not be performed because the cooper lot number was not provided.However, it should be noted at the time of manufacture, records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: while no definitive root cause could be reliably determined, the potential root cause may be that the yellow slide marker became dislodged during the procedure and remained in the vagina until it was expelled during a shower.This is based on the details of the complaint.The yellow slide marker is snapped onto the curette during assembly.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information.

• Brand Name: UTERINE EXPLORA CURETTE - MODEL I
• Common Device Name: 3MM OD CURETTE WITH VACU-LOK SYRINGE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 22479256
• Report Number: 1216677-2025-00038
• Device Sequence Number: 8015920
• Product Code: HHK
• UDI-Device Identifier: 00888937003505
• UDI-Public: (01)00888937003505
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K001545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MX120
• Device Catalogue Number: MX120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian