MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACH ULTRA FREEZE

Model Number	900076
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As per details reported on e-complaint (b)(4) from fs log # 100090.Cryosurgical system bottle freezes on the outside.
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
Bottle freezes on the outside, wallach ultra freeze 900076 e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: the complaint product was manufactured at csi on 01-may-2017 under work order (b)(4) and sold on 30-may-2017.Manufacturing record review: dhr-211866 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: 08-jan-2018 - 87811-not holding pressure-no issues found with the unit-tested ok.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair.However, based on log (b)(4) this unit was at csi on 20-mar-2023.Visual evaluation: visual examination of the complaint product revealed physical damage.The luer lock is bent possibly form being dropped.The bottle returned (2021070008) is from a different unit.Functional evaluation: complaint product was functionally evaluated and found to not function properly.Root cause: the root cause of this issue has been attributed to the bottle that has lost vacuum and the luer lock being bent.It appears to the technician that the unit was dropped.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.The customer has decided to not have the unit repaired.The unit has been scrapped.No further training required at this time.*was the complaint confirmed? yes.

• Brand Name: WALLACH ULTRA FREEZE
• Common Device Name: WALLACH ULTRA FREEZE
• 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: 16708943
• Report Number: 1216677-2023-00060
• Device Sequence Number: 6079987
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K935010
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 900076
• Device Catalogue Number: 900076
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown