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

Model Number KC-RUMI-30

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported on medwatch mw5149899 that the patient sustained a serious injury of an unknown nature during an unknown procedure on (b)(6) 2023.Patient retained foreign object after an alleged product malfunction that required intervention.No contact information provided.No additional information is available.(b)(4).

Manufacturer Narrative

Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information is available.

Manufacturer Narrative

Distribution history the complaint product was manufactured at csi on 09/26/23 under work order (b)(4).Manufacturing record review dhr - 339708 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 did not show similar reported complaint condition.Product receipt the complaint product has not been returned to cooper surgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to cooper surgical.If the unit/product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation nor verification.With the information provided, a root cause analysis cannot be definitively performed.As a way of improving the manufacturing process, csi stafford has implemented 100% in process inspection of the product via bend testing and pull testing, followed by an aql qc inspection requiring the that the units also pass a bend and pull test.Cooper surgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.

• Brand Name: RUMI II KOH-EFFICIENT
• Type of Device: 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: 18631014
• MDR Text Key: 334433665
• Report Number: 1216677-2024-00002
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: (01)00888937015072
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 339708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention