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

Model Number	10067
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Description of event: "md attempting vacuum.Both items broke at the junction where the mushroom cap meets the long plastic arm.Physician questions if the pop off mechanism was working as she felt it should have popped off instead of break." mityone mushroom cup 10067 e-complaint (b)(4).
Event or Problem Description
Customer reported: ""md attempting vacuum.Both items broke at the junction where the mushroom cap meets the long plastic arm".1216677-2020-00255-1 10067 mityone mushroom cup (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation, review dhr, inspect returned samples.Distribution history: the complaint product was manufactured at csi on 5/22 - 5/27-2020 under work order 287262.Manufacturing record review: dhr-10067 - 287262 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 similar reported complaint conditions.Product receipt: the complaint product was returned to csi and confirmed (b)(6) 2021.Visual evaluation: a visual evaluation of the complaint product was completed and confirmed (b)(6) 2021.Functional evaluation: an evaluation of the complaint product could not be completed as the complaint product was returned in a nonfunctional manner due to reported event, see attached email with photos.Root cause: definitive root cause as to the resulting reported event is indeterminable.Pull test supplier data indicated acceptable results.Corrective actions: not applicable as the affected devices were individually tested before packaging and were found to be acceptable.No further action is required at this time.Was the complaint confirmed? yes.

• 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: 10803701
• Report Number: 1216677-2020-00255
• Device Sequence Number: 19463319
• Product Code: HDB
• UDI-Device Identifier: 00888937003123
• UDI-Public: 888937003123
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/07/2023

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 Expiration Date: 05/18/2023
• Device Model Number: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 287262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown