MAUDE Adverse Event Report: COOPERSURGICAL, INC. CODA INLINE FILT FOR CO2

Model Number	CIPR-001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Per details received from user facility on incoming e-complaint (b)(6): "filter flew due to high pressure.Cause: filter was apparently in a line at 60psi, it might have been an accidental increase of pressure.The filters were installed in a line at 60psi" "no injuries.".
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 1/17/2023 under wo #(b)(4).Manufacturing record review: dhr 322809 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint unit was not possible as the unit cannot be returned.Functional evaluation: a functional evaluation of the unit was not possible as the unit cannot be not returned.Root cause: the root cause is attributed to end user error.The ifu states the pressure to use on the device is not to exceed 24 psi.The customer stated the pressure was set to 60 psi, more than double the specified pressure indicated by the ifu.The verbiage suggests the customer concedes the line may have exceeded 60 psi for a short period of time.Note: complaint confirmation is based on the image provided and the information concerning the exposure to high pressure.A review of the ifu confirms clear instruction to not exceed 24 psi when pressurizing the line to the filter.Due to the damage when this unit was exposed to excessive pressure, hhe-23-0193 for coda in-line filters was submitted.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information is available.

• Brand Name: CODA INLINE FILT FOR CO2
• Common Device Name: CODA INLINE FILT FOR CO2
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 17050103
• Report Number: 1216677-2023-00088
• Device Sequence Number: 3491674
• Product Code: MQG
• UDI-Device Identifier: 00815965020938
• UDI-Public: (01)00815965020938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: CIPR-001
• Device Catalogue Number: CIPR-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown