MAUDE Adverse Event Report: COOPERSURGICAL, INC. UTERINE MANIPULATOR TIP B

Model Number	UMB678
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 currently investigating the reported condition.
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.Reference e-complaint (b)(4).1216677-2020-00228 uterine manipulator tip b umb678 e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation: no sample returned.Review dhr.Distribution history: the complaint product was manufactured at csi under work order 285138.Manufacturing record review: dhr-umb678-285138 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 not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.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 product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed.Corrective actions complaint unit has not been returned to coopersurgical so the complaint could not be confirmed.Coopersurgical will continue to trend this complaint condition.No further corrective actions necessary.No further training is required since the complaint was not confirmed.Was the complaint confirmed? no.
Event or Problem Description
Report stated: "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".1216677-2020-00228-1 umb678 uterine manipulator tip b e-(b)(4).

• Brand Name: UTERINE MANIPULATOR TIP B
• Common Device Name: UTERINE MANIPULATOR TIP B
• 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: 10655521
• Report Number: 1216677-2020-00228
• Device Sequence Number: 16881431
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K932115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,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 Expiration Date: 04/08/2023
• Device Model Number: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 285138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2020
• Supplement Date Received by Manufacturer: 09/19/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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