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

Model Number	KC-RUMI-30
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.The actual device involved in the complaint has been returned for evaluation by the customer.Once the investigation is completed a follow-up report will be filled.(b)(4).
Event or Problem Description
Doctor "tested the "donut" outside of the patient and it was fine.Began to use it inside the patient, and only once it was fully inflated did it start to leak - springing out like a fountain onto the operating room fellow." increased length of surgery.
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation; review dhr; inspect returned samples: *analysis and findings dhr review of wo# (b)(4) for pn kc-rumi-30 shows 200 boxes were made in feb 2018 at csi stafford facility.Each box contains five each of the assembled kc-rumi-30 parts each assembled with one occluder pn 23670-1.There were 3 lots (243557, 242842, 244109) of occluder used for assembling the finished goods.Inspections/tests were performed at four levels from molding through assembly into finished parts: 1.After each lot was molded, 100% visual inspections were done and balloon-tested for air-leaks.2.Qc tests of occluder lots included leak testing (8 ea) by injecting 200cc saline in each.3.After assembly, in-process visual inspection is performed in fg lot.Non-conforming parts are culled out including cuts in the occluder.4.Qc completes visual inspections with samples from assembled fg lot.The complaint detail mentions that the initial test of the "donut" which is considered the occluder, went successfully.It was only after the use of the device inside of the patient that the occluder started to leak.The leak was coming from two pin holes.It is highly probable that the occluder may have been punctured with a sharp object, causing the leak, as it was evident that the occluder was not leaking at the time of testing.With manufacturing process 100% testing each occluder with air leak test, and as well as the occluder not leaking during test outside of the patient, it is unlikely that the leak of the occluder can be attributed to a manufacturing issue.In addition, there is no existing source of holes/ cuts identified after koh assemblies at the facility.A leak in the occluder may have been caused by a cut or puncture via usage error.A 2 yr complaint history review was performed and there were other complaints with leaking occluders, however those complaints were shown to have cuts on the occluders that were punctured with sharp object.Correction and/or corrective action: complaint will be monitored for trending in that no injury was reported to end user or patient.Not determined to be a manufacturing issue.Was the complaint confirmed? yes.
Event or Problem Description
Doctor tested the "donut" outside of the patient and it was fine.Began to use it inside the patient, and only once it was fully inflated did it start to leak - springing out like a fountain onto the or fellow.Koh-efficient,rumi,3-0cm kc-rumi-30 (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,3.0CM
• Common Device Name: KOH-EFFICIENT,RUMI,3.0CM
• 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: 7960659
• Report Number: 1216677-2018-00057
• Device Sequence Number: 19259181
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: 888937015072
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 244093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown