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	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Freezing up.Both pins look rusty.Spare pin is also rusty.Fs log # 99321.1216677-2022-00298 wallach ultra freeze 900076 (b)(4).
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
Freezing up.Both pins look rusty.Spare pin is also rusty.Wallach ultra freeze 900076 (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 23-jul-2013 under work order (b)(4) and sold on 31-jul-2013.Manufacturing record review: dhr-146479 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: 82460- 27-may-2016- pressure valve cracked.88698- 11-apr-2018- worn main valve.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 99321 this unit was at csi on 20-oct-2022.Visual evaluation: visual examination of the complaint product revealed that the valve plunger is corroded.Functional evaluation: 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.The valve plunger is corroded and the seal worn.*correction and/or corrective action: the complaint unit was repaired and returned to the customer.The main valve plunger was replaced.The unit was tested and found acceptable.Coopersurgical will continue to trend this complaint condition.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: 15781408
• Report Number: 1216677-2022-00298
• Device Sequence Number: 17417423
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 10/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2013
• 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