MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 1PK CARTRGE; M3

Catalog Number	33518
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when they went to use the cryosolutions 1pk cartridge (33518) all the gas came out.There have been no reports of patient involvement, injury, or surgical delay associated with this incident.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigations, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The cryosolutions 1pk cartridge (33518) was not returned to the manufacturer after three good faith effort (gfe) attempts to retrieve the product.Lot number information was provided; device history record (dhr) was reviewed, and no abnormalities related to the reported issue was observed.Thus, a definitive root cause cannot be determined.The issue of gas coming out may be the result of damage to the o-ring on the customer's control unit or incompletely installing the cartridge.The customer is directed to follow the cryosolutions instructions for use (ifu) for appropriate assembly and handling.

• Brand Name: CRYOSOLUTIONS 1PK CARTRGE
• Common Device Name: M3
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21297604
• Report Number: 3014334038-2025-00008
• Device Sequence Number: 18452849
• Product Code: GEH
• UDI-Device Identifier: 10381780171973
• UDI-Public: 10381780171973
• Combination Product (Y/N): N
• PMA/510(K) Number: K091721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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 Catalogue Number: 33518
• Device Lot Number: 7358183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Patient Sex: Unknown