MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACH ULTRA FREEZE

Model Number 900076

Device Problems Complete Blockage (1094); Pressure Problem (3012); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

Event Type  malfunction  

Event Description

Not spraying.No pressure.(b)(4).Confirmed complaint:main valve blockage and plunger stuclk.Wallach ultra freeze 900076 (b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Not spraying.No pressure.Order: (b)(4).Confirmed complaint:main valve blockage and plunger stuclk 1216677-2021-00242 wallach ultra freeze (b)(4).

Manufacturer Narrative

Investigation x-inspect returned samples analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 10-27-2009 under wo # (b)(4) and shipped on 01-20-2010.Manufacturing record review: a review of the device history record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: this unit was serviced in 2014 , 2016 and 2020 for a damaged trigger.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on log 97096 this unit was at csi on 09/28/2021.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the unit had a blockage of particles, most likely from a dirty dewar.The dewar is used to refill the bottle.The root cause is being attributed to end user error.The ifu, under the filling instructions, directs the user to have the source container of the liquid nitrogen cleared out several times a year.Was the complaint confirmed? yes.Correction and/or corrective action the blockage was cleared and the on/off valve was cleaned.The unit was tested and found to be acceptable and was returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.

• Brand Name: WALLACH ULTRA FREEZE
• Type of Device: 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: 12753733
• MDR Text Key: 283171425
• Report Number: 1216677-2021-00242
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other