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

Model Number	KC-RUMI-35
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currenlty investigating the reported condition.
Event or Problem Description
Report submitted by (b)(4) territory manager- i am getting in touch as we have recently started seeing the new design of koh-cup in the (b)(6).I have used this twice now with 2 different surgeons and feel as though there are a couple issues that have come up.Firstly, the cup is not gliding along the handle as well as the old design, and have found there is no click when it gets into place once the cup has been moved into position.With the cup not gliding as smoothly and not having the wings, this results in surgeons squeezing it slightly causing them to miss the locking point.Finally we had an incident where the rumi handle was removed from the patient and the cup and uterus were left inside.No sure how the cup came detached.In my eyes this was product failure, however the surgeon does not feel the need to report it.Three follow-up attempts has been made to the contact to complete complaint form, provide product details, and other incidents.(b)(6) 2021- update to complaint account stated "isolated as only used this cup once, however when demonstrating the product this has happened several times with the new design".(b)(4).Koh-efficient rumi 3-5 cm kc-rumi-35 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned, review dhr.*analysis and findings, distribution history, the complaint product was manufactured at csi on 09/02/20 under work order (b)(4).Manufacturing record review dhr - 293504 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 did not show similar reported complaint condition.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, any findings will be appended to this investigation.However, the complaint condition will be confirmed based on the image provided.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.From looking in the device history, a design change was made validated under val-19-0247-r with results showing that the component was able to be produced reliably with negligible impact on the product and its function.The ifu (rumikoh-ifu-b) of the rumi states that the device is slid into place by pressing on the push pad.It is unknown if the device was pressed on the push pad for sliding into the correct position.If the unit/product should be returned at a later date, any pertinent findings will be appended to this investigation.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation.It is unknown if the user was not able to lock down because the device wasn't engaged prior to sliding, or whether the kc-rumi was slid into place via pressing the push pad as per the ifu.*correction and/or corrective action 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.No further training required at this time.*was the complaint confirmed? no.
Event or Problem Description
We have recently started seeing the new design of koh-cup in the uk.I have used this twice now with 2 different surgeons and feel as though there are a couple issues that have come up.Firstly, the cup is not gliding along the handle as well as the old design, and have found there is no click when it gets into place once the cup has been moved into position.With the cup not gliding as smoothly and not having the wings, this results in surgeons squeezing it slightly causing them to miss the locking point.Finally we had an incident where the rumi handle was removed from the patient and the cup and uterus were left inside.Not sure how the cup came detached.In my eyes this was product failure, however the surgeon does not feel the need to report it.Koh-efficient rumi 3-5cm kc-rumi-35 (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Common Device Name: KOH-EFFICIENT,RUMI,3.5CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11125899
• Report Number: 1216677-2020-00312
• Device Sequence Number: 3718022
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K954311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 293504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown