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

Model Number 900076

Device Problems Partial Blockage (1065); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Will not spray confirmed complaint: partial blockage in main valve.Bad relief device seal.Cleared blockage and replaced relief device seal.Repair order (b)(4).1216677-2022-00130 wallach ultra freeze 900076 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.Review dhr.Inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 12/22/2016 under wo #(b)(4) and shipped on 01/06/2017.Manufacturing record review: dhr 195185 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was serviced in 2017 for a main valve replacement.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 no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit's relief valve had a bad seal and there was a blockage in the main valve.Root cause: blockage in the main valve indicates the liquid nitrogen source was not clean coming from the dewar.Root cause is being attributed to handling and wear & tear.Corrective actions the unit was repaired, 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.Confirmed complaint: partial blockage in main valve.Bad relief device seal.Cleared blockage and replaced relief device seal.Repair order (b)(4).1216677-2022-00130-1 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: 14252050
• MDR Text Key: 298710471
• Report Number: 1216677-2022-00130
• 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: 04/29/2022
• 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: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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