MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACH ULTRA FREEZE; GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL

Model Number	900076
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while freezing spots, the lever kept sticking.No adverse event reported.No additional information available.900076 ultra 2023-08-0000163.
Additional Manufacturer Narrative
Customer has indicated that the product is in process of being returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 06-25-21 under work order (b)(4) and sold on 01-aug-2021.Manufacturing record review: (b)(4) 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.However, based on log 100748 this unit was at csi on 08-aug-2023.Visual evaluation: visual examination of the complaint product revealed no physical damage.The bottle returned with the unit is from a different unit (serial number (b)(6).Functional evaluation: complaint product was functionally evaluated and found not to function properly.Root cause: the root cause of this issue has been attributed to the main valve stem/seal being misshaped.This issue is being attributed to the valve stem/seal being over crimped in the assembly process.The complaint unit was repaired and returned to the customer.The valve stem was replaced.The unit was tested and found to be acceptable.Coopersurgical will continue to trend this complaint condition.The operators were retrained to the procedure.
Event or Problem Description
No additional information is available.

• Brand Name: WALLACH ULTRA FREEZE
• Common Device Name: GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17610629
• Report Number: 1216677-2023-00120
• Device Sequence Number: 20511432
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: (01)00888937010961
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/16/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown