MAUDE Adverse Event Report: COOPERSURGICAL, INC. ARCH KOH-EFFICIENT; COLPOTOMY TUBE

Model Number	KC-ARCH-30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic assisted laparoscopic hysterectomy, the blue ring on koh-efficient device came apart from white body of item when attempting to remove patient's uterus through vagina.Blue ring inside patient's pelvis when it came apart and was removed by the doctor.No patient harm.No additional information available.Kc-arch-30 koh-efficient 2025-05-0000066.
Additional Manufacturer Narrative
Device is being returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 3 sep 2024.Manufacture record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: review of the 2-year complaint history did show a similar reported complaint condition however in that case it was not confirmed and no definitive root cause could be determined, since the product was not returned for investigation nor verification.Product receipt: the complaint product was returned to coopersurgical on 27 may 2025.Visual evaluation: evaluation of the complaint product showed glue residue on the cup and the cup was off the assembly.Functional evaluation: functional evaluation showed that upon reinsertion, the cup fit tight into the assembly.Root cause: a possible root cause may be that the product was not handled properly.The returned device has a cup detached from the main body of the kc-arch, but visual and functional inspection, including dhr review indicate that the product was manufactured appropriately.Inventory stock product was checked to see if any product from lot: 550014672 was available for investigation, but none was found.To mitigate cup detachment, csi stafford performs 100% in process inspection of the product via bend test, followed by an aql qc inspection requiring the units also pass bend/pull test.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition is determined to not be an manufacturing issue.
Event or Problem Description
No additional information.

• Brand Name: ARCH KOH-EFFICIENT
• Common Device Name: COLPOTOMY TUBE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 22123644
• Report Number: 1216677-2025-00032
• Device Sequence Number: 7266324
• Product Code: HEW
• UDI-Device Identifier: 00888937015157
• UDI-Public: (01)00888937015157(10)550014672
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/18/2025

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 Model Number: KC-ARCH-30
• Device Catalogue Number: KC-ARCH-30
• Device Lot Number: 550014672
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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
• Patient Sex: Female