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

Model Number	10067
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by (b)(6) on behalf of end-user- we have receive a customer complaint with regard to the use of a mityone vac device (lot: 271732).The customer has reported the following: the mityone was being used for a birth.It was the 4th pull of the vacuum when the product snapped at the base of the cup.There was no loss of suction at any point in time prior to this and the suction strength was in the green zone on the product.The customer has since confirmed that the new born was not injured as a result of the incident.We have the product ready for return to coopersurgical for evaluation.Mityone mushroom cup 10067 (b)(4).
Additional Manufacturer Narrative
Investigation no sample returned review dhr.*analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 04/23/2020 under wo # (b)(4).Manufacturing record review: dhr (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.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 condition.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.Root cause: root cause not applicable as the complaint condition was not confirmed.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.*was the complaint confirmed? no.
Event or Problem Description
The mityone was being used for a birth.It was the 4th pull of the vacuum when the product snapped at the base of the cup.There was no loss of suction at any point in time prior to this and the suction strength was in the green zone on the product.The customer has since confirmed that the new born was not injured as a result of the incident.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: 12222806
• Report Number: 1216677-2021-00146
• Device Sequence Number: 14244123
• Product Code: HDB
• UDI-Device Identifier: 00888937003123
• UDI-Public: 888937003123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/13/2023

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: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 271732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/25/2021
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown