MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,3.0CM

Model Number	KC-ARCH-30
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currenlty investigating the condition reported.
Event or Problem Description
Report submitted by csi rep.Incident report: blue colpotomy part of koh cup separated during robotic total hysterectomy and was left remaining inside of patient.Colpotomy cup was recovered before case ended, and entire lot has been sequestered.(b)(4).
Event or Problem Description
Incident report: blue colpotomy part of koh cup separated during robotic total hysterectomy and was left remaining inside of patient.Colpotomy cup was recovered before case ended, and entire lot has been sequestered.Kc-arch-40 was opened for demonstration of event and also separated from the cup.1216677-2020-00206-1 koh-efficient arch 3-0cm kc-arch-30 (b)(4).
Additional 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 03/13/20 under work order (b)(4).Manufacturing record review dhr - 287394 was reviewed and no non-conformities, related to the complaint condition, were noted.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 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, any findings will be appended to this investigation.However, the complaint condition will be confirmed based on the image provided.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, any pertinent findings will be appended to this investigation.Root cause no definitive root cause for this issue could be reliably determined at this time, since the product was not returned for investigation.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 (archkohadv-dfu).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.*correction and/or corrective action.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.No further training required at this time.*was the complaint confirmed? yes.

• Brand Name: KOH-EFFICIENT,ARCH,3.0CM
• Common Device Name: KOH-EFFICIENT,ARCH,3.0CM
• 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: 10520763
• Report Number: 1216677-2020-00206
• Device Sequence Number: 14337145
• Product Code: HEW
• UDI-Device Identifier: 00888937015157
• UDI-Public: 888937015157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 287394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown