MAUDE Adverse Event Report: COOPERSURGICAL, INC. OPTHALMIC CRYO SYSTEM DIG

Model Number	CE-2000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
Customer stated-probe would not unfreeze to remove from patient's eye repair tech-batts low, foot pedal valve leaks, auto shut off bad (b)(4).Opthalmic cryo system dig ce-2000.E-complaint (b)(4).
Additional Manufacturer Narrative
Investigation inspect returned samples distribution history: this complaint unit was manufactured in 2010 and shipped 12/30/2010.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: this unit was serviced in 2014 requiring an adjustment to the regulator, a back flush and replacement of a muffler.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 foot pedal was found to have leaks, the battery was low, and the auto-shut off was not operating.Root cause: the root cause is being attributed to wear and tear given the age of the device.Corrective actions the unit was repaired, tested 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 not unfreeze to remove from patient's eye".Ce-2000 opthalmic cryo system dig e-complaint (b)(4).

• Brand Name: OPTHALMIC CRYO SYSTEM DIG
• Common Device Name: OPTHALMIC CRYO SYSTEM DIG
• 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: 12566463
• Report Number: 1216677-2021-00211
• Device Sequence Number: 19948428
• Product Code: HQA
• UDI-Device Identifier: 00888937009422
• UDI-Public: 888937009422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: CE-2000
• Device Catalogue Number: CE-2000
• Device Lot Number: -
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/02/2021
• Supplement Report FDA Received Date: 01/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown