MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT; KOH-EFFICIENT,RUMI,3.5CM

Model Number KC-RUMI-35

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that the patient underwent a procedure on (b)(6) 2023.The patient did not require a hysterectomy and only an oophorectomy (removal of one of the ovaries).The equipment was removed from the patient.There was no post vaginal exam which is typical for a vaginal hysterectomy.The patient then came in for a 3 month post check and the koh cup was discovered and removed when the vaginal exam was conducted.1216677-2024-00011 kc-rumi-35 koh-efficient 2024-02-0000684.

Manufacturer Narrative

User submitted an mdr to the fda with reference number 4500760000-2024-8001.Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Updated: b4, g3, g6, h2, h3, h6, h11.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.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 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.The complaint condition will be confirmed with the photo provided.Functional evaluation: 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, since the product was not returned for investigation.To mitigate cup detachment, 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 Description

No additional information is available.

• Brand Name: RUMI II KOH-EFFICIENT
• Type of Device: KOH-EFFICIENT,RUMI,3.5CM
• 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: 18920861
• MDR Text Key: 337863664
• Report Number: 1216677-2024-00011
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 888937015089
• UDI-Public: (01)888937015089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female