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	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
Event or Problem Description
As per details reported on e-complaint (b)(4) from fs log # (b)(4)."the unit/bottle is leaking." wallach ultra freeze 900076 e-complaint (b)(4).
Event or Problem Description
The unit/bottle is leaking.1216677-2023-00031-1 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 12-may-2014 under work order 160420 and sold on 16-may-2014.Manufacturing record review: dhr-160420 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: 28-may-2019 - 92072-leaks-relief device not sealing properly.04-jan-2021 - 95493-trigger broken off.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 99825 this unit was at csi on 01-feb-2023.Visual evaluation: visual examination of the complaint product revealed no physical damage.It was identified that the bottle returned is a different serial number than the unit returned.The bottle has 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 relief device not sealing properly to allow pressure to build.This is being attributed to normal wear and tear.Correction and/or corrective action: the relief valve was cleaned and adjusted.The unit was tested and found acceptable.The unit was returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.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: 16460313
• Report Number: 1216677-2023-00031
• Device Sequence Number: 6459010
• Product Code: GEH
• UDI-Device Identifier: 00888937010961
• UDI-Public: 888937010961
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/20/2023

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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2014
• 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