MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,3.5CM; COLPOTOMY TUBE

Model Number	KC-ARCH-35
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hysterectomy on (b)(6) 2024.During the procedure, the doctor was using the kc-arch-35 and experienced the cup becoming displaced while the locking mechanism was still engaged.The doctor opened the lock, replaced the manipulator with the cup in the proper location and re-closed the locking mechanism.The cup slid out of place a second time.The cup was replaced and no further issues occurred.Unfortunately, the cup displacement resulted in an unintended organ injury.It was easily repaired and the patient is fine with no expected complications.Kc-arch-35 koh-efficient (b)(4).
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Distribution history: a distribution history record review was not possible for this product as the lot number was not provided for investigation.Manufacturing record review: a dhr review was not possible as a lot number was not provided.Historical complaint review: a review of the 2-year complaint history did not show any similar complaint conditions, this is determined to be an isolated incident.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.Root cause: no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation.Per ifu of the device for proper assembly: position the koh-efficient's squeeze clamp over the loading zone and press firmly on the thumb pad, in the direction of the arrow, to snap into place.It is possible that the product was assembled incorrectly causing it to slip, this incident is an isolated event.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective actions required as the complaint was not confirmed.

• Brand Name: KOH-EFFICIENT,ARCH,3.5CM
• 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: 20224290
• Report Number: 1216677-2024-00052
• Device Sequence Number: 3393542
• Product Code: HEW
• UDI-Device Identifier: 00888937015164
• UDI-Public: (01)00888937015164
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female