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	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Freezes with use and sprays nitrogen uncontrolled.Fs log # 98991.Wallach ultra freeze 900076 e-complaint-(b)(4).
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
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 25-jun-2021 under work order (b)(4) nd sold on (b)(6)2021.Manufacturing record review: (b)(4) as 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.However, based on log (b)(4) his unit was at csi on (b)(6) 2022.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found not to function properly.Unit was spraying uncontrollably and freezes.Root cause: the root cause of this issue has been attributed to the dip tube getting slightly bent by the customer.This than caused the end of the dip tube to contact the bottom of the cannister which prevented the cannister cap to be able to be closed completely and caused the leakage and freezing.*correction and/or corrective action the dip tube was adjusted and the unit was tested ok to (b)(4).Coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.*was the complaint confirmed? yes.
Event or Problem Description
Freezes with use and sprays nitrogen uncontrolled.Wallach ultra freeze 900076 (b)(4).

• 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: 15349892
• Report Number: 1216677-2022-00251
• Device Sequence Number: 5206493
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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