MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,3.0CM

Model Number KC-RUMI-25

Device Problems Leak/Splash (1354); Defective Device (2588); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currenlty investigating the condition reported.

Event Description

Report forwarded by csi ra- i received a report from health canada for a device that was defective and wanted to bring this to your attention.Incident detail.Rumi balloon tore at seam and starting leaking normal saline from balloon intraoperatively, rumi handle had to be removed and balloon and adapter changed intraoperatively. .Additional information- procurement made aware of issue with device, as surgeons did express that this had happened previously with this medical device.Lot number given to procurement to keep track of and was also going to contact rep to make them aware of same.  1216677-2022-00107 koh-efficient rumi 3-0cm kc-rumi-30 e-complaint-(b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.*analysis and findings distribution history the complaint product was manufactured at csi on 07/19/2021 under work order (b)(4).Manufacturing record review dhr - (b)(4) 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 where the occluder started leaking during the procedure.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.However, the complaint condition is very similar to other complaints as mentioned earlier.In those complaints, the device started leaking during the procedure.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation nor verification.It should be noted that the dfu of the device (rumiiikoh-dfu) states that the device should be tested by inflation of the occluder with 20-60 cc of saline prior to usage.The complaint states that the device was leaking during the procedure, indicating that the product was tested and was working prior to the leak.A possible root cause of this may be that the occluder encountered a sharp object during usage.Other complaints of occluder leakage were also attributed to the product encountering a sharp object when complaint product was returned for investigation.*correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report forwarded by csi ra- i received a report from health canada for a device that was defective and wanted to bring this to your attention.Incident detail.Rumi balloon tore at seam and starting leaking normal saline from balloon intraoperatively, rumi handle had to be removed and balloon and adapter changed intraoperatively. .Additional information- procurement made aware of issue with device, as surgeons did express that this had happened previously with this medical device.Lot number given to procurement to keep track of and was also going to contact rep to make them aware of same.  1216677-2022-00107 koh-efficient rumi 3-0cm kc-rumi-30 (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.0CM
• Type of Device: KOH-EFFICIENT,RUMI,3.0CM
• 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 ; 4752651665
• MDR Report Key: 14073599
• MDR Text Key: 295809240
• Report Number: 1216677-2022-00107
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: KC-RUMI-25
• Device Catalogue Number: KC-RUMI-25
• Device Lot Number: 305309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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