MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; KOH-EFFICIENT,RUMI,3.0CM BOX OF 5

Model Number	KC-RUMI-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: japan.Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Patient 2/3.It was reported that during an unknown procedure, the rumi koh-efficient was used and lacerated the vaginal wall.No obvious defect in the device was found.Sutures were required to stop bleeding.No additional information is available.Kc-rumi-30 koh-efficient (b)(4).
Additional Manufacturer Narrative
Updated.Distribution history a distribution history record review was not possible for this product as the lot number was not provided for investigation.Manufacturing record review a dhr review was not possible as a lot number was not provided.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 cooper surgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.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 #1.Lot number was not provided stating that: the product itself has not been found to be defective.#2.Kc-sizer was 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 is to be noted that the complainant acknowledges that the product itself was not found to be defective.No lot number was provided for investigation, however we performed our investigation to find out all lot numbers for kc-rumi-30 shipped to origio japan (csi distribution facility in japan) in past 3 years.Based on further review, no ncmrs were identified for the listed lot numbers for flash/sharp edges that may potentially cause laceration.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: KOH-EFFICIENT,RUMI,3.0CM BOX OF 5
• 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: 20089218
• Report Number: 1216677-2024-00046
• Device Sequence Number: 7580903
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: 00888937015072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown