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	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total laparoscopic hysterectomy and ovarian tumor reception, the cup detached from the kc-arch-35 upon extraction of the device from the patient's cavity.Cup was not retained in the patient's cavity.No patient harm.No additional information.Device is not available to return.Kc-arch-35 koh-efficient 2024-11-0000164.
Additional Manufacturer Narrative
G2: foreign: colombia.Device location is unknown.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 18 dec 2023.Manufacturing record review: dhr - 346485 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.Any relevant customer or clinical information: the following customer or clinical information was provided: the complaint condition will be confirmed using the pictures attached in e-mail, it is to be noted that the product in the picture looks clean without any blood/stain marks.Root cause: no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for further investigation.With the information provided, a root cause analysis cannot be definitively performed.As a way of improving the manufacturing process, csi stafford performs 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 any trends.
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: 20756863
• Report Number: 1216677-2024-00064
• Device Sequence Number: 18248390
• Product Code: HEW
• UDI-Device Identifier: 00888937015164
• UDI-Public: (01)00888937015164(10)346485(17)261220
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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-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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/15/2025
• 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