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

Model Number	10057
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Multiple report submitted by supplier/distributor - per report - breakage during use.Mystic ii mushroom cup 10057 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation: no sample returned, review dhr.Analysis and findings: complaint (b)(4).Distribution history: the complaint products were manufactured at csi.Manufacturing record review: dhr-10057 -248041 was reviewed and no abnormalities were noted.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.None were against the lot number 248041.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.Correction and/or corrective action: no corrective actions applicable at this time.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required at this time.Was the complaint confirmed? no.
Event or Problem Description
Breakage during use.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: 11792264
• Report Number: 1216677-2021-00088
• Device Sequence Number: 13683375
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 248041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 02/10/2023
• 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