MAUDE Adverse Event Report: COOPERSURGICAL, INC. PRO-STAY 8/PK

Model Number	3205-8G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
As per details reported on incoming (b)(4): "during surgery the consultant removed the elastic stay from the patient and observed that the tip had broken off.He located and removed the broken tip from the patient." "the procedure was an anterior and posterior repair and was performed under a general anesthesia.".
Event or Problem Description
During surgery the consultant removed the elastic stay from the patient and observed that the tip had broken off.He located and removed the broken tip from the patient.1216677-2023-00021-1 pro-stay 8 pk 3205-8g e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation.No sample returned.Review dhr.*analysis and findings.Distribution history.The complaint unit was manufactured at csi on 12/14/21 under work order (b)(4).Manufacturing record review.Dhr-313715 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review.The incoming inspection review is not applicable for this product.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.While photos were submitted with the complaint, they could not be accessed.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 was not returned to coopersurgical.If the product should become available at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause.No definitive root cause for this issue could be reliably determined at this time.Should any further information regarding this complaint be made available the complaint will be updated accordingly.*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 is required at this time.*was the complaint confirmed? no.

• Brand Name: PRO-STAY 8/PK
• Common Device Name: PRO-STAY 8/PK
• 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: 16285854
• Report Number: 1216677-2023-00021
• Device Sequence Number: 4757862
• Product Code: GAD
• UDI-Device Identifier: 00888937015461
• UDI-Public: 888937015461
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K791665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 3205-8G
• Device Catalogue Number: 3205-8G
• Device Lot Number: 313715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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