MAUDE Adverse Event Report: COOPERSURGICAL, INC. MYSTIC II,MUSHROOM CUP

Model Number	10057
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
During the procedure the product broke.1216677-2021-00144 mystic ii, mushroom cup 10057 (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples.Distribution history the complaint product was manufactured at csi on 12/17/2020 under work order (b)(4).Manufacturing record review dhr 297214 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 attached did not show similar reported complaint conditions.Product receipt the complaint product has been returned to coopersurgical via rma #319283, 6/22/2021.Visual evaluation evaluation of the complaint products confirmed units were used and heavily soiled with blood from the handle to within the cup.None were broken.Functional evaluation evaluation of the complaint products (3 units) confirmed the units were able to reach the green zone with the cup on a gloved hand.This was done repeatedly.The levers to release the pressure were functional.The gauge read steady and the pressure was maintained after the trigger was no longer being exercised.Root cause functionally the units were not exhibiting failures in pressure or activation.The end of the cup where the stem meets may be extended virtually 90 degrees without breaking.If broken the seal would be compromised and the unit would not function.The levers to release pressure were functional on all three units as well.The root cause for this complaint is not applicable as the units were not broken and functional.Corrective actions the units were retained.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.
Event or Problem Description
Customer reported: "during the proceedure the product broke".10057 mystic ii mushroom cup e-complaint (b)(4).

• Brand Name: MYSTIC II,MUSHROOM CUP
• Common Device Name: MYSTIC II,MUSHROOM CUP
• 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: 12150922
• Report Number: 1216677-2021-00144
• Device Sequence Number: 4447512
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011532
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10057
• Device Catalogue Number: 10057
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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