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	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As per details reported on e-complaint (b)(4) from fs log # 100112 cryosurgical system "leaking airgass.".
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
As per details reported on (b)(4) from fs log # (b)(4).Cryosurgical system "leaking airgass.".
Additional Manufacturer Narrative
Investigation: x-review dhr: x-inspect returned samples.*analysis and findings: complaint (b)(4).Distribution history: the complaint product was manufactured at csi on 25-apr-2016 under work order (b)(4) and sold on 18-aug-2016.Manufacturing record review: dhr-195178 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no service history record found for this product.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.Visual evaluation: visual examination of the complaint product revealed no physical damaged.Functional evaluation: complaint product was functionally evaluated and found to function properly.Root cause: root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.The unit was tested with liquid nitrogen per form-prod 282 and was found acceptable.No further training required at this time.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• 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.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16709351
• Report Number: 1216677-2023-00062
• Device Sequence Number: 7454244
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/16/2023

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
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/16/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown