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

Model Number	900076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Distribution history: the complaint unit was manufactured at csi on 27/sep/2018 and sold on 18/dec/2018.Manufacturing record review: dhr was reviewed, and no non-conformities related to the complaint condition were noted.Incoming inspection review the incoming inspection review is not applicable for this product.Service history record: the unit was, previously, returned on 16/jul/2020 for a broken needle tip; this was attributed to end user mishandling.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions attributed to end user mishandling.Product receipt: the complaint unit was returned on 19/jun/2023 visual evaluation: visual examination of the complaint unit revealed physical damage: the trigger lever was disconnected from the unit and the needle was broken.Functional evaluation: complaint unit was evaluated and found not to function properly due to the damaged components.The condition indicates that unit suffered some form of impact damage.Root cause: while no definitive root cause could be reliably determined, this issue may have been due to end user mishandling.The aperture kit was replaced.The unit function was verified, and it was returned to the customer.Coopersurgical will continue to trend this complaint condition.
Event or Problem Description
It was reported that the handle to release was broken.No adverse event reported.No additional information available.900076 ultra freeze 2023-06-0000400.

• 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; VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651582
• MDR Report Key: 17299003
• Report Number: 1216677-2023-00101
• Device Sequence Number: 3874841
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: (01)00888937010961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 2018090011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2018
• 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