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

Model Number	900076
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Trigger lever gets stuck.Fs log# 99264.1216677-2022-00285 wallach ultra freeze 900076 (b)(4).
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Additional Manufacturer Narrative
Investigation findings: the complaint product was manufactured at csi on 03-nov-2017 and sold on 28-dec-2017.Device history record was reviewed, and no non-conformities related to the complaint condition were noted.A review of the two-year complaint history showed similar reported complaint conditions.The complaint unit was returned on a repair on 10/oct/2022.Visual examination of the complaint product revealed no physical damage.Complaint product was functionally evaluated and found not to function properly.Root cause: while no definitive root cause could be reliably determined, the potential cause may be from normal wear and tear.Corrective actions: the complaint unit was repaired and returned to the customer.The relief device was replaced.The unit was tested and found acceptable.Coopersurgical will continue to trend this complaint condition.
Event or Problem Description
Company representative confirmed "relief device not sealing to allow unit to build pressure.".

• Brand Name: WALLACH ULTRA FREEZE
• Common Device Name: WALLACH ULTRA FREEZE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15658554
• Report Number: 1216677-2022-00285
• Device Sequence Number: 14882027
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K935010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2017
• 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