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

Model Number KC-RUMI-35

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

(b)(4).Additional report in ref.To (b)(4).Report stated "product not sliding along the rumi ii handle, to click into place.Noticed design was different, so thought it was a design fault, however new cup looked the same and had the same issue with not gliding easily.Resulted in surgeon missing the cup locking into position, device had to be removed and taken apart, before being put back into the patient.Additional info-once we had the equipment out, its clear that the new design doesn't lock in as easily and can pop out of the grooves.Koh-efficient rumi 3-5 cm kc-rumi-35 (b)(4).

Manufacturer Narrative

Follow up to initial filing for : ai coopersurgical.Mdr 1216677-2021-00003.1.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.Please see the table below for the information requested.Mdr report # csi e-complaint # model/catalog # lot # 1216677-2021-00003 (b)(4) kc-rumi-35 293504.2.Describe the parts or components of the devices that are not "not sliding along the rumi ii handle, to click into place".Provide a schematic of the reported device(s) and indicate where on the schematic the "new design doesn't lock in as easily and can pop out of the grooves" occurred.The reported condition of difficulty sliding the koh-efficient mechanism or sleeve along the arm and locking it in place is indicated below in red.The sleeve component is designed to slide along the rumi ii handle where the lock tab features will engage with the rumi ii handle at the location indicated below in red.3.Please describe any design change(s) or modification(s) to the device, since the device was initially introduced to the market that may be related to the event.Please also include the date(s) the design change(s) or modification(s) occurred.There have been no design changes to date that impact the functionality of the koh-efficient locking mechanism.The last design change to date was cosmetic in nature requested by marketing and initiated on june 1, 2020 under engineering change notice (ecn) 23619.The ecn for the rumi ii smooth koh-efficient was to improve the outer contours of the sleeve and sleeve extension to better align the outer surfaces of these components.This was in an effort to offer a more streamlined assembled device profile.A risk-based assessment was conducted and concluded that there is no impact on the fit or function of the rumi ii koh-efficient configurations identified above as a result of this change.4.Please provide a copy (or electronic location) of all current labeling for the device, including directions for use, caution statements, technical manuals, and product performance reports.Below is a link to the directions for use and any product performance literature from the coopersurgical website.Https://www.Coopersurgical.Com/detail/rumi-ii-system-with-koh-efficient-technology/ all current labeling for the display box and tyvek lid are attached for reference.5.Please identify the exact location in the labeling where users are warned of steps to take to prevent the reported problem from occurring, and/or how to mitigate the problem should it occur.The instructions for use (ifu) that accompany this product provide the following guidance under steps 4, 5, & 8, as well as the precautions section with regard to securing the koh-efficient in place to mitigate this failure mode.6.What quality control procedures and testing does your firm employ to ensure outgoing product meets design and performance specifications? describe acceptance and rejection criteria and specify sampling procedures.The design change implemented under ecn (b)(4) was validated under val-19-0247-r, revision b for the rumi smooth sleeve extension molding component, which was the subject component of the reported complaint.The validation found that the component was able to be produced in a consistent and reliable manner with negligible impact on the product and its function.Additionally, this component is inspected during production testing of the kc rumi steps 1 & 2 in the form of retention testing using a pull tester and torque tester under test method ms-050013 for the kc-rumi koh-efficient assembly as a control identified in risk management file rmf0037-pfmea, item 116 to mitigate for a failure effect of components separating during use.The sampling plan is based on an acceptable quality level (aql) identified in standard operating procedure sp-4701, attribute sampling plan while ms-063009, koh efficient function testing method sheet, outlines the acceptance and rejection criteria.7.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device report are or are not attributable to the device.No additional details were provided by the account associated with this complaint after several good faith efforts nor is the subject product available for evaluation.However, a review of the complaint history for this product line and reported condition since the design change on june 1, 2020, noted that this issue is isolated to this account in the united kingdom.While (b)(4) units have been distributed since the implementation of the new design.**coopersurgical, inc.Is currently investigating the reported condition.Once the investigation has completed a final report will be submitted **.

Event Description

E-complaint-(b)(4).Additional report in ref.To e-complaint-(b)(4).Report stated "product not sliding along the rumi ii handle, to click into place.Noticed design was different, so thought it was a design fault, however new cup looked the same and had the same issue with not gliding easily.Resulted in surgeon missing the cup locking into position, device had to be removed and taken apart, before being put back into the patient.Additional info-once we had the equipment out, its clear that the new design doesn't lock in as easily and can pop out of the grooves.1216677-2021-00003 koh-efficient rumi 3-5 cm kc-rumi-35 e-complaint-(b)(4).

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 record not applicable to this product.Historical complaint review a review of the 2-year complaint history did show similar reported complaint condition.(unconfirmed complaint).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.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 (b)(6) 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 Description

Report stated "product not sliding along the rumi ii handle, to click into place.Noticed design was different, so thought it was a design fault, however new cup looked the same and had the same issue with not gliding easily.Resulted in surgeon missing the cup locking into position, device had to be removed and taken apart, before being put back into the patient.Once we had the equipment out, its clear that the new design doesn't lock in as easily and can pop out of the grooves on 1216677-2021-00003-2 koh-efficient rumi3-5cm kc-rumi-35 (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Type of Device: 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: 11222539
• MDR Text Key: 234413279
• Report Number: 1216677-2021-00003
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• 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
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other