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

Model Number	10057
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported condition.
Event or Problem Description
Incident details surrounding event:the patient was placed in the lithotomy position.When pulled second time, the tube was torn off.Detail to procedure stated "when the tube's edge broke, the physician's right hand holds the handle with her left hand placed.The product was vertical to the head of infant when the incident occurred." patient reported to experience bleeding and baby was delivered by forceps method, not by vacuum extraction.(b)(4).Mystic ii mushroom cup 10057.
Event or Problem Description
The patient was placed in the lithotomy position.When pulled second time, the tube was torn off.Detail to procedure stated "when the tube's edge broke, the physician's right hand holds the handle with her left hand placed.The product was vertical to the head of infant when the incident occurred." patient reported to experience bleeding and baby was delivered by forceps method, not by vacuum extraction.Mystic ii mushroom cup 10057 (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, issued to work order 254348 as csi part number 10057 and completed 11/06/2018.Manufacturing record review dhr-10057-254348 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc record-18-11-03-021 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 confirmation of the reported balloon rupture event was obtained through provided attached photos.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 no definitive root cause for this issue could be reliably determined at this time.*correction and/or corrective action corrective action is not applicable at this time due to the absence of the affected sample for investigative analysis.No further training required at this time; complaint will be monitored for trending.*was the complaint confirmed? yes.

• 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: 9993433
• Report Number: 1216677-2020-00098
• Device Sequence Number: 16663364
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/06/2023

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: 254348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 02/06/2023
• 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