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

Model Number KC-RUMI-35

Device Problems Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Event 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).

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported on mw report number report (b)(4).

Event 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.".

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
• Type of Device: 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
• MDR Text Key: 301093137
• Report Number: 1216677-2022-00263
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Race: White