MAUDE Adverse Event Report: COOPERSURGICAL, INC. N20 CV RETINAL SUPER

Model Number	161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported condition is being investigated by coopersurgical, inc.
Event or Problem Description
Not reading temp.Order: 94589.Ref e-complaint-(b)(4).N20 cv retinal super 161 e-complaint-(b)(4).
Event or Problem Description
Customer stated: "the equipment did continue to work in order to complete the procedure.The temperature just would not continue reading for the doc to see exactly what temp it was at".161 n20 cv retinal super (b)(4).
Additional Manufacturer Narrative
Investigation: inspect returned samples: review dhr.Distribution history: this complaint unit was manufactured at csi on 8/25/2014 under wo #: (b)(4) and shipped on 8/12/2015.Manufacturing record review: dhr (b)(4) was reviewed and no non-conformities were noted.Incoming inspection review: not applicable.Service history record: this unit was returned once in 2015 (log 80853) with no issues confirmed.In july of 2019 the unit was returned (log 92463) for a tear in the silicone tubing.Historical complaint review: a review of the 2-year complaint history showed no 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 had the blue thermocouple wire was pinched.Root cause: a pinched thermocouple wire is consistent with no readings.The assembly requires the wires reside next to the feeder tubing all within the boiler.Initial testing for a readout is executed on each unit during production.A failure of this kind indicates the boiler was incorrectly manipulated by the end user creating the likelihood of a pinched wire inside.Corrective actions: the unit was repaired, tested to specifications and returned to the customer.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? yes.

• Brand Name: N20 CV RETINAL SUPER
• Common Device Name: N20 CV RETINAL SUPER
• 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: 10398637
• Report Number: 1216677-2020-00172
• Device Sequence Number: 11510825
• Product Code: HQA
• UDI-Device Identifier: 00888937004069
• UDI-Public: 888937004069
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 161
• Device Catalogue Number: 161
• 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: 07/24/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2014
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown