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	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
The trigger press stays active and the liquid nitrogen keeps spraying.Wallach ultra freeze 900076 (b)(4).
Event or Problem Description
The trigger press stays active and the liquid nitrogen keeps spraying 1216677-2022-00277 wallach ultra freeze 900076 (b)(4).
Additional Manufacturer Narrative
Investigation no sample returned review dhr *analysis and findings complaint (b)(4) distribution history: this complaint unit was manufactured at csi on 10/288/2021 under wo #(b)(4) and shipped on 11/23/2021.Manufacturing record review: dhr 278444 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was placed on rma 337508.However, the unit was not received as of 12/12/2022.Visual evaluation: a visual evaluation could not be completed as the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: an evaluation could not be completed as the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: a root cause is not determinable as no unit was returned for an evaluation.*correction and/or corrective action no further corrective action is necessary.No further training required.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
Additional Manufacturer Narrative
Product receipt: the complaint unit was returned for repair.Visual evaluation: a visual inspection revealed that the plunger stem was over pressed.Functional evaluation: a functional test of the returned device confirmed the complaint condition.Root cause: a definitive root cause cannot be determined at this time.However, based on other repaired units with a similar problem, the replacement of the plunger resulted in smoother movement, thus resolving the issue.
Event or Problem Description
No additional information is available.Wallach ultra freeze 900076 (b)(4).

• 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 drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15596170
• Report Number: 1216677-2022-00277
• Device Sequence Number: 2136757
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: (01)00888937010961
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022; 09/06/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/20/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown