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	08/23/2018
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
Customer stated "one of our customers returned a batch of 20 pcs, 10057 mystic ii pump w/mushroom cup, batch n° 230218.2 pcs of the 10057 were completely broken while delivering the baby, so we replaced them immediately to satisfy customer 18 pcs of the same batch were returned by the same customer as they doesn't trust the quality of them." (b)(4).
Event or Problem Description
Customer stated "one of our customers returned a batch of (b)(4), 10057 mystic ii pump w/mushroom cup, batch n° 230218.(b)(4) were completely broken while delivering the baby, so we replaced them immediately to satisfy customer.(b)(4) of the same batch were returned by the same customer as they doesn't trust the quality of them." 1216677-2018-00071-1 mystic ii mushroom cup 10057 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation, initiated manufacturer's investigation, no sample returned, review dhr.*analysis and findings the reported complaint event cannot be verified or analyzed due to the absence of the affected mystic ii, mushroom cup and pump device in that it was not returned.Should the affected device be returned in the future, the complaint may be reopened and amended as needed.A definitive root cause for the reported event cannot be determined without the actual device used in the reported event., however, in reviewing past complaint analysis and attributing to past potential root cause, it's likely that the device may have been subjected to use in a manner contrary to its intended use or function.A review of the two-year complaint history indicated that there were no other similar complaints reported previously.A review of the csi manufacturing assembly process indicated that nothing had been changed, and work instructions were being properly followed and adhered to.It should be noted that both the pump and mushroom cup assembly are 100% visually and functionally evaluated for acceptability.A review of the lot dhr for work order 230218 was performed and did not reveal any abnormalities.*correction and/or corrective action corrective action is not applicable at this time due to the absence of the affected sample for proper investigative analysis that assists in ascertaining a potential root cause.Per 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: 8070352
• Report Number: 1216677-2018-00071
• Device Sequence Number: 1913445
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: 888937003109
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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 Expiration Date: 09/28/2020
• Device Model Number: 10057
• Device Catalogue Number: 10057
• Device Lot Number: 230218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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