MAUDE Adverse Event Report: COOPERSURGICAL, INC. WA4000 20# N20 CONN

Model Number	900509-4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.
Event or Problem Description
Defrost button is not defrosting.(b)(4).Wa4000 20 n20 conn 900509-4.
Event or Problem Description
Customer stated: "defrost button is not defrosting".1216677-2020-00126-1 900509-4 wa4000 20 n20 conn (b)(4).
Additional Manufacturer Narrative
Investigation inspect returned samples distribution history: this complaint unit was manufactured at csi in 2008.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.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 device history record be located going forward, it will be reviewed and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: unit was returned to csi under log 81344 2/9/2016 for a leak on the ll100 section of the unit and the "on/off" valve in the console.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit was contaminated with cold soak residue inside the ll100 section of the unit.Root cause: the root cause is being attributed to end user error.The ll100 section is to be wiped down with a disinfectant only.Other methods are not recommended including cold soaks.Corrective actions the unit was repaired, cleaned, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.Was the complaint confirmed? yes.

• Brand Name: WA4000 20# N20 CONN
• Common Device Name: WA4000 20# N20 CONN
• 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: 10095898
• Report Number: 1216677-2020-00126
• Device Sequence Number: 16968472
• Product Code: GEH
• UDI-Device Identifier: 00888937014020
• UDI-Public: 888937014020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K813024
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 900509-4
• Device Catalogue Number: 900509-4
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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