MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,2.5CM

Model Number KC-RUMI-25

Device Problem Burst Container or Vessel (1074)

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 submitted by csi rep.Incident detail: i received a phone call from an operating room nurse last saturday regarding an accident while using the product cpo6.It was at the end of a surgery and the inflated balloon of the cpo6 was suddenly blew out with unknow reason.A tiny piece of the product cpo6 was found missing and it could not be found again after a thorough search.Koh-efficient rumi 2-5cm kc-rumi-25 (b)(4).

Event Description

Report submitted by csi rep.Incident detail- i received a phone call from an operating room nurse last saturday regarding an accident while using the product cpo6.It was at the end of a surgery and the inflated balloon of the cpo6 was suddenly blew out with unknow reason.A tiny piece of the product cpo6 was found missing and it could not be found again after a thorough search.02/17/2022- update- the product involving in this complaint was definitely the kc-rumi-25.It has nothing to do with the cpo-6.This discrepancy was mainly because the nurse reported to me was cpo-6 on the day of incidence.Procedure being performed lavh.*did the physician perform any extra step to complete the procedure/how did physician complete the procedure/was there any fragment left in the patient? i was not there and the incidence was reported by a nursing in-charge of the operating theatre.The procedure of course was completed by the physician and no doubt about it.However, a tiny piece of balloon material was found missing and could not be retrieved after a thorough search.This is why they want to have a letter to specify the material that is being used to manufacture the balloon material of kc-rumi-25.Was there any significant delay as result of the reported condition? 30 mins delay? the nurse didn't mention it.I guess it wasn't an issue for them.(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 04/28/21 under work order 303355.Manufacturing record review dhr - 303355 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 occluder started leaking during the procedure.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional 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 not be reliably determined 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 occluder leaked/ruptured during the procedure, indicating that the product was tested and was working prior to the leak/rupture.A possible root cause of this may be that the occluder encountered a sharp object during usage.Other complaints of occluder leak were also attributed to the product encountering a sharp object when complaint product was returned for investigation.The occluder is made from medical grade silicone and has not undergone any recent design changes.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*was the complaint confirmed? no.

• Brand Name: KOH-EFFICIENT,RUMI,2.5CM
• Type of Device: KOH-EFFICIENT,RUMI,2.5CM
• 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: 13664763
• MDR Text Key: 289256709
• Report Number: 1216677-2022-00060
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KC-RUMI-25
• Device Catalogue Number: KC-RUMI-25
• Device Lot Number: 303355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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