MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; RUMI II KOH-EFFICIENT- 3.0 CM FOR USE WITH THE RUMI II HANDLE

Model Number	KC-RUMI-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient 2/5.It was reported that during a hysterectomy procedure, when the rumi koh-efficient was placed into the vagina, it caused major vaginal lacerations.Doctor is concerned that the cup is defective.Device was discarded.No additional information is available.1216677-2024-00035 kc-rumi-30 koh-efficient 2024-08-0000012.
Additional Manufacturer Narrative
Device had been discarded by the hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 12 oct 2023.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.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 showed similar reported complaint conditions, however in those cases the complaint condition was not confirmed.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.Any relevant customer or clinical information: kc-sizer was not used prior to performing the procedure.Root cause: no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation.It should be noted that the ifu of the device on page 2, number 3 states that: using the sizer, determine the proper size of koh-efficient.A possible root cause of the failure may be attributed to the kc-sizer not being used as noted in the follow-up.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: RUMI II KOH-EFFICIENT
• Common Device Name: RUMI II KOH-EFFICIENT- 3.0 CM FOR USE WITH THE RUMI II HANDLE
• 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: 19929087
• Report Number: 1216677-2024-00035
• Device Sequence Number: 20868172
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072(10)339715(17)261012(240)KC-RUMI-30
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 339715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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: Required Intervention
• Patient Sex: Female