MAUDE Adverse Event Report: COOPERSURGICAL, INC. N20 RETINAL PRB STRAIGHT

Model Number	124
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported condition.
Event or Problem Description
Customer stated-probe would form an ice ball but when applying to a patient it would not continue to form the ice ball.Repair tech-high freeze flow 16mm ro (b)(4).N20 retinal prb straight 124 e-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation inspect returned samples distribution history: this complaint unit was manufactured at csi on 09/14/2009 under wo #(b)(4) and shipped on 1/30/2010.Manufacturing record review: a review of the device history 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 quality release specifications.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed 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.The gas flow was no longer optimal and found to flow too fast to produce the target temperature at the tip.Root cause: the air flow is dependent on the position of the ball seating properly so that the gas produces a temperature drop at the tip and maintain that temperature through that gas flow.This unit was noted to have the ball seating past optimal position.A root cause for this complaint condition is not readily available but given the device has been in service for 11 years with no record of being serviced this is considered wear and tear.Continual use may be pushing the ball out of optimal position and impacting the opening over time.Corrective actions the unit's spring assembly was repaired, tested to specification 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.Was the complaint confirmed? yes.
Event or Problem Description
Customer stated: "probe would form an ice ball but when applying to a patient it would not continue to form the ice ball".124 n20 retinal prb straight (b)(4).

• Brand Name: N20 RETINAL PRB STRAIGHT
• Common Device Name: N20 RETINAL PRB STRAIGHT
• 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: 12561048
• Report Number: 1216677-2021-00208
• Device Sequence Number: 4459953
• Product Code: HQA
• UDI-Device Identifier: 00888937004144
• UDI-Public: 888937004144
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): N
• 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: 124
• Device Catalogue Number: 124
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/27/2023
• 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