MAUDE Adverse Event Report: COOPERSURGICAL, INC. CRYO PLUS W/20 LB CYL YOK

Model Number 2400

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation process is completed a follow-up report will be filed.(b)(4).

Event Description

"per repair authorization form " provider stating thaw cycle not working.(b)(4).

Manufacturer Narrative

Reference e-complaint (b)(4).Investigation: x-review dhr, x-inspect returned samples.Analysis and findings: the unit, serial# (b)(4), was built in june of 2016 and shipped in september of 2017.A review of the 2 years complaint history for cryo plus w/20 lb cyl yok, p/n-2400 reveals one similar issue.The dhr-2400-va0505 was reviewed and found no anomalies during production.Repair order (b)(4) note: won't defrost.Delivery tube clogged.Cleaned delivery tube and line.Tested to qa spec.The complaint was confirmed.As per repair tech, improper cleaning after each use may results in clogged inside, due to this clogged the delivery line was not working properly.It should be noted that all cryo plus w/20 lb cyl yok units are tested 100% prior to release.Therefore, while no definitive root cause could be reliably determined, this issue may be attributed to customer mishandling.Coopersurgical will continue to monitor this complaint condition for trends.

Event Description

"per repair authorization form " provider stating thaw cycle not working.Order: (b)(4)." ref e-complaint (b)(4).

• Brand Name: CRYO PLUS W/20 LB CYL YOK
• Type of Device: CRYO PLUS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8574914
• MDR Text Key: 144142435
• Report Number: 1216677-2019-00068
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2400
• Device Catalogue Number: 2400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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