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

Model Number	KC-RUMI-30
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: foreign: japan.The customer has indicated that the device will be returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a fragment of koh cup resin was found in the abdominal cavity while cleaning in tlh treatment.The doctor asks what will happen if the fragments of resin are not collected.It is reportable in japan.No additional information is available.1216677-2024-00004 kc-rumi-30 koh-efficient 2024-01-0000404.
Additional Manufacturer Narrative
Distribution history: a distribution history record review was not possible for this product as the product lot number was not provided for investigation.Manufacturing record review: a dhr review was not possible as a lot number was not provided.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 did not show similar reported complaint conditions.Product receipt: the complaint product was returned to coopersurgical on 01/30/2024.Visual evaluation: visual evaluation of the product shows that the product has melted.It was also noticed that the product was missing the occlude balloon.Functional evaluation: functional evaluation not applicable for this complaint condition.Root cause: based on the visual investigation, it is possible that the product was used with a harmonic or other types of ultrasonic or laser, causing the product to melt and leave fragments.Possible root cause can be attributed to 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 ifu (rumi-ii-koh-efficient-ifu) under the warnings section.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.
Event or Problem Description
No additional information is available.

• Brand Name: RUMI II KOH-EFFICIENT
• Common Device Name: 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 ; 4752651582
• MDR Report Key: 18717314
• Report Number: 1216677-2024-00004
• Device Sequence Number: 11591801
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Female