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	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
E-complaint- (b)(4).Incident details surrounding event- metal wire tore through tip and ended up in the bladder.Patient status-had to suture a defect in the bladder.1216677-2021-00052 uterine manipulator tip b umb678 e-complaint (b)(4).
Event or Problem Description
Customer stated: "metal wire tore through tip and ended up in the bladder.Patient status-had to suture a defect in the bladder".1216677-2021-00052-1 umb678 uterine manipulator tip b (b)(4).
Additional Manufacturer Narrative
Investigation no sample returned review dhr distribution history the complaint product was manufactured at csi in september 2020 under work order (b)(4).Manufacturing record review dhr 285208 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 one other 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.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 coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.Was the complaint confirmed? no.

• 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: 11570719
• Report Number: 1216677-2021-00052
• Device Sequence Number: 3546399
• Product Code: LKF
• UDI-Device Identifier: 00888937001402
• UDI-Public: 888937001402
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): N
• 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): 01/30/2023

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: UMB678
• Device Catalogue Number: UMB678
• Device Lot Number: 285208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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