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

Model Number 900076

Device Problems Partial Blockage (1065); Break (1069); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

Will not spray and sticks confirmed complaint: luer lock broken off.Nozzle bent.Main valve partially blocked.Replaced luer lock.Straightened nozzle.Cleared blockage.Repair order (b)(4).1216677-2022-00117 wallach ultra freeze 900076 e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Manufacturer Narrative

Investigation.Review dhr inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 03/07/2019 under wo #(b)(4) and shipped on 09/03/2019.Manufacturing record review: dhr 248286 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.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed physical damage with a bent nozzle and a broken off luer lock.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit also had a partially blocked valve.Root cause: the damage is due to handling error by the end user.The blockage in the main valve is also deemed as an end user handling error.This device is to be filled with liquid nitrogen from a clean source.Typically, dewars are used to refill the bottle which must be kept clean as any particulate will be transferred to the bottle and taken up by the feed tube on this device.Corrective actions the unit was repaired, cleaned, tested and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required.*was the complaint confirmed? yes.

Event Description

Will not spray and sticks.Confirmed complaint: luer lock broken off.Nozzle bent.Main valve partially blocked.Replaced luer lock.Straightened nozzle.Cleared blockage.Repair order (b)(4).1216677-2022-00117-1 wallach ultra freeze 900076 e-complaint(b)(4).

• Brand Name: WALLACH ULTRA FREEZE
• Type of Device: 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: 14175829
• MDR Text Key: 297430936
• Report Number: 1216677-2022-00117
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other