MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,4.0CM

Model Number	KC-ARCH-40
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersugical, inc.Is currently investigating the reported condition.
Event or Problem Description
"when the uterine manipulator was removed by the surgeon it was noted to be apart.The blue plastic end was no longer attached.All pieces found and removed from the patient.Arch koh-efficient 4.0 broke intraoperatively." e-complaint- (b)(4).Koh-efficient arch 4-0cm kc-arch-40 e-complaint- (b)(4).
Event or Problem Description
When the uterine manipulator was removed by the surgeon it was noted to be apart.The blue plastic end was no longer attached.All pieces found and removed from the patient.Arch koh-efficient 4.0 broke intraoperatively.Koh-efficient arch 4-0cm kc-arch-40 e-(b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation: review dhr.Inspect returned samples.Analysis and findings: distribution history.The complaint product was manufactured at csi on 03/25/20 under work order (b)(4).Manufacturing record review.Dhr - 287842 was reviewed and no non-conformities were noted.Incoming inspection review.Incoming inspection record review not applicable to this product.Serv.History record.Service history record not applicable to this product.Hist.Complaint review.A review of the 2-year complaint history did show similar reported complaint condition.Product receipt.The complaint unit was returned 11/13/20.Vis.Eval.Visual examination of the complaint units revealed that the cup was detached from the sleeve.The unit, as returned, did not have the occluder attached present.It is confirmed that glue was applied during manufacture of the device, indicating that device was assembled appropriately.Functional.Eval.Complaint product was functionally evaluated and found not to function properly due to the cup being detached.Root cause no definitive root cause for this issue could be reliably determined at this time, with the information provided in the complaint.The returned device has a cup detached from the main body of the kc-arch, but visual inspection, including dhr review indicate that the product was manufactured appropriately.The returned product was missing the occluder.It is unknown how the product was used, however, from the complaint condition, a cup detachment may have been caused by handling of the device.The ifu (archkoh-ifu) mentions that the occluder needs to be deflated prior removal of device.It is unknown if the occluder was deflated during the removal, which could cause a cup detachment.To mitigate cup detachment, csi stafford has implemented 100% in process inspection of the product via bend test, followed by an aql qc inspection requiring the units also pass bend/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,4.0CM
• Common Device Name: KOH-EFFICIENT,ARCH,4.0CM
• 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: 10655695
• Report Number: 1216677-2020-00229
• Device Sequence Number: 13595969
• Product Code: HEW
• UDI-Device Identifier: 00888937015171
• UDI-Public: 888937015171
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Consumer,Health Professional,User Facility
• 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 Expiration Date: 03/25/2023
• Device Model Number: KC-ARCH-40
• Device Catalogue Number: KC-ARCH-40
• Device Lot Number: 287842
• 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: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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