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

Model Number	10057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
Event or Problem Description
We try to use suction cup during an emergency cesarean section, the product was not functional.(postponement of the intervention, prolongation of hospitalization, loss of transient function) widespread disorganization, malfunction of the service.
Additional Manufacturer Narrative
Distribution history the complaint product was manufactured at csi in july 2018.Manufacturing record review the dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the vad device was visually evaluated in the bio-lab and it was found to be free of any obvious damage as returned inside a small corrugated box in a glad zip-lock bag.Visual evaluation the vad device was visually evaluated in the bio-lab and it was found to be free of any obvious damage.Functional evaluation the vad device was functionally tested on a bio-lab tabletop and using a small latex glove to create a seal on which a vacuum could be manually pulled and attained.The vad was able to attain proper vacuum and maintain it without any leak during testing for over five minutes before the vacuum was released.The functional testing was re-performed several times, and each time the vad performed as intended.Root cause root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
It was reported that the cup was used during an emergency cesarean section, but the cup was not functional.No harm reported to mother or baby.No additional information has been provided.Mystic ii mushroom cup 10057 e-complaint (b)(4).

• Brand Name: MYSTIC II,MUSHROOM CUP
• Common Device Name: MYSTIC II,MUSHROOM CUP
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull VA 06611
• Manufacturer Contact: michael marone ; 2400 hunter's way; charlottesville, VA 22911 ; 4752651582
• MDR Report Key: 8424635
• Report Number: 1216677-2019-00129
• Device Sequence Number: 14209756
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: (01)00888937003109(10)248041(17)210629
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 06/29/2021
• Device Model Number: 10057
• Device Catalogue Number: 10057
• Device Lot Number: 248041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• 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: Female