MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,4.0CM

Model Number KC-RUMI-40

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currenlty investigating the reported condition.

Event Description

During assembly of the 4.0 cup and handheld dr said koh cup crumbled and could not used.Koh-efficient rumii 4-0cm kc-rumi-40.E-complaint: (b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned review dhr analysis and findings distribution history the complaint product was manufactured at csi on 03/11/21 under work order (b)(4).Manufacturing record review dhr - 300565 was reviewed and revealed a non-conformity that was unrelated to the complaint condition.The work order was reworked, reinspected and passed qc inspection.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 show similar reported complaint conditions, however, the complaint unit was not returned for proper investigation.Product receipt the complaint product has not been returned to coopersurgical.Visual 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.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation.Correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint was not confirmed.No further training required at this time.Was the complaint confirmed? no.

Event Description

During assembly of the 4.0 cup and handheld dr said koh cup crumbled and could not be used.Koh-efficient rumi 4 cm kc-rumi-40 e-complaint (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,4.0CM
• Type of Device: KOH-EFFICIENT,RUMI,4.0CM
• 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: 11796927
• MDR Text Key: 261026176
• Report Number: 1216677-2021-00097
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: KC-RUMI-40
• Device Catalogue Number: KC-RUMI-40
• Device Lot Number: 300565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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