MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYONE MUSHROOM CUP

Model Number	10067
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
Event or Problem Description
The mushroom cup failed during a delivery.(b)(4).
Additional Manufacturer Narrative
Investigation.Initiated manufacturer's investigation.Review dhr.*analysis and findings.The returned sample was not available at the time of this investigation (9/13/19), should the sample be located and made available for complaint investigation analysis, the complaint may be reopened and addressed as needed.Inventory review indicated that the lot was fully depleted and no longer available for verification.A review of the two-year product complaint history indicated one other similar reported event.A review of the csi lot (233891) dhr indicated the m-cup subassembly lot to have been lm234079.Dhr review did not indicate any abnormalities.Supplier spc data indicated the pull force on the cup subassembly to have been well above the 41lbs minimum.Past complaint history similar in nature have indicated that it's not a device failure, as much as the device failure may have been the result of using the device contrary to indicated use instructions.Based on the information available, no further action is required.It should be noted that each completed vad device is individually accessed for visual and functional acceptance before being packaged, sterilized and released to fg warehouse.Correction and/or corrective action.Corrective active action is not warranted at this time as the affected device was not available for investigative analysis.All past complaint testing has not been able to replicate the type of reported event when used in accordance with the ifu instruction guidelines.Per bsr-qar-026 this complaint will be monitored for trending in that no injury was reported to end user, or patient.*was the complaint confirmed? no.
Event or Problem Description
The mushroom cup was damaged during a delivery.1216677-2018-00097-1 mityone mushroom cup 10067 (b)(4).

• Brand Name: MITYONE MUSHROOM CUP
• Common Device Name: MITYONE 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: 8219308
• Report Number: 1216677-2018-00097
• Device Sequence Number: 10812303
• Product Code: HDB
• UDI-Device Identifier: 00888937003123
• UDI-Public: 888937003123
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K890307
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 09/15/2020
• Device Model Number: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 233891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2017
• 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