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

Model Number	10057
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
"(b)(6) called to report that mystic mushroom broke during delivery process they replaced with another one.Does not have product was thrown out and this occured on (b)(6) 2021 and was reported today".Mystic ii,mushroom cup 10057.E-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation: no sample returned.Analysis and findings: complaint (b)(4).Distribution history: the complaint product was manufactured at csi, but the lot number was not provided.So, the date of manufacture is not available and the dhr could not be reviewed.Manufacturing record review: a review of the device history record could not be performed because the lot number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: incoming inspection record review not applicable to this product.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 training required at this time.Was the complaint confirmed? no.
Event or Problem Description
Mystic mushroom broke during delivery process.They replaced with another one.Does not have product, was thrown out and this occured on (b)(6) 2021 and was reported (b)(6) 2021.She does not have a lot number.1216677-2021-00120-1 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: 11940097
• Report Number: 1216677-2021-00120
• Device Sequence Number: 3662394
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/13/2023

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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 02/13/2023
• 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