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

Model Number	KC-RUMI-35
Medical Device Problem Codes	Defective Component (2292); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Rumi instrument used during hysterectomy for uterine manipulation was melted with harmonic in process.Small flakes from end of rumi found floating in specimen container and some pieces of rumi were removed from patient during case by doctor.Koh-efficient rumi 3.5cm e-complaint: (b)(4), mw report (b)(4).
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the condition reported on mw report number report (b)(4).
Event or Problem Description
Healthcare professional reported "rumi instrument used during hysterectomy for uterine manipulation was melted with harmonic in process.Small flakes from end of rumi found floating in specimen container and some pieces of rumi were removed from patient during case by doctor.".
Additional Manufacturer Narrative
Investigation findings: the complaint product was manufactured at csi on 02/16/22.Device history record (dhr) was reviewed and no non-conformity, related to the complaint condition, were noted.A review of the 2-year complaint history did not show similar reported complaint conditions.The complaint product has not been returned to coopersurgical.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.Root cause: the root cause of this issue has been attributed to the improper usage of the device which lead to the melting of the cup (made from ultem).The kc-rumi line of products is not intended to be used with a harmonic or other types of ultrasonic or laser.This is mentioned in the included dfu (p/n rumiiikoh-dfu) under the warnings section.Although the kc-rumi product is not intended for use with a harmonic scalpel, csi has the kcs-rumi family of product that was designed for use with harmonic scalpels.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint was not manufacturing issue.

• Brand Name: KOH-EFFICIENT,RUMI,3.5CM
• Common Device Name: KOH-EFFICIENT,RUMI,3.5CM
• 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: 15485496
• Report Number: 1216677-2022-00263
• Device Sequence Number: 5256108
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/01/2023

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 Expiration Date: 02/16/2025
• Device Model Number: KC-RUMI-35
• Device Catalogue Number: KC-RUMI-35
• Device Lot Number: 315285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Race: White