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

Model Number	10057
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported condition.
Event or Problem Description
Medwatch form_uf_importer report #-(b)(4)- and medwatch5094030.A mushroom vacuum instrument broke during an instrument assisted delivery.Details provided by the delivery note stated " a total of 3 pulls were performed and 2 popoffs occurred.Two reapplications were performed with the third pull, the mushroom vacuum handle broke with cup left on the fetal head which was removed.The fetal head had made descent.After the vacuum broke, push continued with maternal expulsive efforts with contraction" no harm to patient and new born.(b)(4).1216677-2020-00124 mystic ii mushroom cup (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation; no sample returned, review dhr.*analysis and findings: distribution history the 53347 m-cup sub assy.Mystic was purchased from carclo technical plastics and received 6/22/2019, issued to work order (b)(4) as csi part number 10057 and completed 10/29/2019.Manufacturing record review: dhr-10057 - 271719 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc inspection record 22835146 was reviewed and no non-conformities, related to the complaint condition, were noted.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 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 required at this time, complaint will be monitored for trending.*was the complaint confirmed? no.
Event or Problem Description
Medwatch form_uf_importer report # (b)(4) and medwatch5094030.A mushroom vacuum instrument broke during an instrument assisted delivery.Details provided by the delivery note stated "a total of 3 pulls were performed and 2 popoffs occurred.Two reapplications were performed with the third pull, the mushroom vacuum handle broke with cup left on the fetal head which was removed.The fetal head had made descent.After the vacuum broke, push continued with maternal expulsive efforts with contraction" no harm to patient and new born.1216677-2020-00124-1 mystic ii mushroom cup 10057 (b)(4).

• Brand Name: MYSTIC II,MUSHROOM CUP
• Common Device Name: MYSTIC II,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: 10085670
• Report Number: 1216677-2020-00124
• Device Sequence Number: 3386592
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 10057
• Device Catalogue Number: 10057
• Device Lot Number: 271719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/25/2020
• Supplement Report FDA Received Date: 02/08/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown