MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; KOH-EFFICIENT,RUMI,2.5CM

Model Number	KC-RUMI-25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Abnormal Vaginal Discharge (2123)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated: b4, g3, g4, g6, h2, h3, h6, h11.Distribution history the complaint product was manufactured at csi stafford.Manufacturing record review a review of the device history record could not be performed because the lot/serial 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.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did show 1 similar complaint condition.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause no definitive root cause for this issue could be reliably determined at this time, the product was not returned for evaluation and no further evidence of the product being detached was provided to support the complaint condition.As a way of improving the manufacturing process, csi stafford has implemented 100% in process inspection of the product via bend testing and pull testing, followed by an aql qc inspection requiring the that the units also pass a bend and pull test.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Patient underwent laparoscopic acessa ultrasound guided radiofrequency fibroid ablation, diagnostic hysteroscopy, hysteroscopic myomectomy, diagnostic laparoscopy on (b)(6) 2024.No issues at time of procedure.Follow up appointment due to increased vaginal discharge.Hard plastic blue object wedged deep in vagina over cervix.Foreign body removed by provider manually with two-digit exam.Inspected and noted to be the cervical cage portion of the rumi manipulator that was used for acessa surgery.The distal portion of the ring of the manipulator appeared to have snapped off of the rest of the ring device.No injury to patient.Kc-rumi-25 koh-efficient (b)(4).

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: KOH-EFFICIENT,RUMI,2.5CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19215913
• Report Number: 1216677-2024-00020
• Device Sequence Number: 6904400
• Product Code: HEW
• UDI-Device Identifier: 00888937015065
• UDI-Public: (01)00888937015065
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K954311
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: KC-RUMI-25
• Device Catalogue Number: KC-RUMI-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UMB678 DISPOSABLE UTERINE MANIPULATOR TIP UNK LOT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female