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

Model Number	900076
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: foreign: canada.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.
Event or Problem Description
It was reported that the luer lock nozzle is bent and the trigger has broken off.No adverse event reported.No additional information is available.900076 ultra 2023-08-0000339.
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 06/14/2018 under wo # (b)(4) and shipped on 06/28/2018.Manufacturing record review: dhr (b)(4) 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.Descriptions are similar, but this unit was damaged.Product receipt: the complaint unit was returned on a repair.However, based on log 100806, this unit was at csi on 08/18/2023.Visual evaluation: visual examination of the complaint unit revealed physical damage.The trigger came apart but not broken and the luer lock was bent.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the damage was visually confirmed and would impact proper function.The luer lock is made of steel and would require significant force to bend it.A drop is deemed the reason for the damage.The unit was repaired and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.
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: 17610308
• Report Number: 1216677-2023-00122
• Device Sequence Number: 20688318
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 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: 08/18/2023
• Supplement Date Received by Manufacturer: 10/08/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2018
• 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