MAUDE Adverse Event Report: COOPERSURGICAL, INC. ZUI UTERINE INJECTOR

Model Number	ZSI1152
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currenlty investigating the reported condition.
Event or Problem Description
Per the details received on incoming e-complaint(b)(4): "there is a blue piece that comes off the manipulator, we had a patient that had the blue piece left inside of her and it fell out about 30 days after the surgery.".
Additional Manufacturer Narrative
Investigation x-no sample returned x-review dhr.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 28-feb-2022 under wo (b)(4) and shipped on 09-jan-2023.Manufacturing record review: dhr-316714 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-53171 lot number m20570 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no 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.This lot number has been depleted from inventory.Root cause: there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.No definitive root cause for this issue could be reliably determined at this time.Correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
Per the details received on incoming e-complaint (b)(4)."there is a blue piece that comes off the manipulator, we had a patient that had the blue piece left inside of her and it fell out about 30 days after the surgery.".

• Brand Name: ZUI UTERINE INJECTOR
• Common Device Name: ZUI UTERINE INJECTOR
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16709139
• Report Number: 1216677-2023-00061
• Device Sequence Number: 20681749
• Product Code: LKF
• UDI-Device Identifier: 00888937013634
• UDI-Public: 888937013634
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K941457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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
• Device Model Number: ZSI1152
• Device Catalogue Number: ZSI1152
• Device Lot Number: 316714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown