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

Model Number	KC-ARCH-35
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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a robotic hysterectomy/myomectomy, that the blue koh cup detached from white koh efficient sleeve upon removal of the uterine specimen.The blue koh cup remained in patient's vaginal canal after withdrawing the arch; and the cup had to be retrieved by scrub tech after specimen removal.There was no patient harm.Kc-arch-35 koh-efficient 2024-08-0000170.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 18 dec 2023.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint condition.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: 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: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the unit/product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Any relevant customer or clinical information: based on the provided photo of the product with separated cup, this complaint condition has been confirmed.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.It is unknown if the customer used a sizer (kcp) to determine the proper size koh-efficient to use, this is listed under the dfu of the product.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.Coopersurgical 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.
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
• 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: 20127524
• Report Number: 1216677-2024-00049
• Device Sequence Number: 15308005
• Product Code: HEW
• UDI-Device Identifier: 00888937015164
• UDI-Public: (01)00888937015164(10)346485(17)261220
• 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): 10/17/2024

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-35
• Device Catalogue Number: KC-ARCH-35
• Device Lot Number: 346485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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