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

Model Number	10057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
Event or Problem Description
"there is a depression of the cup.And the cup does not hold.They have to reset the pressure." (b)(4).
Event or Problem Description
There is a depression of the cup.And the cup does not hold.They have to reset the pressure.1216677-2018-00049-1 mystic ii mushroom cup 10057 (b)(4).
Additional Manufacturer Narrative
Investigation initiated manufacturer's investigation no sample returned analysis and findings the affected returned vad device for 2018-08-0000078, same device, customer, and condition, but different event, was verified to have been free of any obvious damage and functioned as intended.The affected device was not returned for investigative analysis as no rma was issued, in addition, a dhr review was not performed as lot number was reported as "unknown".*correction and/or corrective action corrective action is not applicable based on the investigative analysis of (b)(4), and that the affected device was not returned.Per bsr-qar-026 this complaint will be monitored for trending in that no injury was reported to end user, or patient.*was the complaint confirmed? no.

• 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: 7955977
• Report Number: 1216677-2018-00049
• Device Sequence Number: 1773472
• 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): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 09/11/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/11/2018
• 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