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

Model Number	10067
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6), inc.Is currently investigating the reported condition.
Event or Problem Description
The mityone product failure occurred on (b)(6) 2021 32 y.O.Patient, second pregnancy, first attempted vaginal delivery arom with meconium present vacuum assisted delivery was initiated after attempts to achieve an unassisted delivery.Two successful pulls with the mityone m-style mushroom cup with fetal head travel third pull resulted in cup failure.The m-style mushroom cup separated from the stem the attending physician, dr.(b)(6), noticed fetal scalp bruising and elected to perform a c-section rather than attempt additional pulls with a new mityone m-style mushroom cup.C-section was successful.Mother and baby are well (apgar score of 9) and no additional medical attention was required.(b)(6) reported the event to fda.Mityone mushroom cup 10067 e-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned review dhr.Distribution history the complaint products were manufactured at csi.Manufacturing record review dhr-10067 - 270750 was reviewed and no abnormalities were noted.Incoming inspection review incoming inspection record review not applicable to this product.Supplier pull test results of subassembly part number 53474, lot lm237545 were acceptable, above the 41lbs minimum with results of > cpk 2.0, see attached.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 not returned to csi.Visual evaluation a physical device 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 an 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.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? no.
Event or Problem Description
Report stated: "the mityone product failure occurred on 1-08-21.32 y.O.Patient, second pregnancy, first attempted vaginal delivery.Two successful pulls with the mityone m-style mushroom cup with fetal head travel.Third pull resulted in cup failure.The m-style mushroom cup separated from the stem.C-section was successful.Mother and baby are well (apgar score of 9) and no additional medical attention was required.10067 mityone mushroom cup e-complaint (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: 11339676
• Report Number: 1216677-2021-00016
• Device Sequence Number: 19768859
• 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): 02/07/2023

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: 10067
• Device Catalogue Number: 10067
• Device Lot Number: 270750
• Was Device Available for Evaluation?: No
• 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: 01/21/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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