MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 4PK CARTRGE; M3

Catalog Number	33517
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the cryosolutions 4pk cartridge (33517) canister leaked or sprayed "cryo" when attached to the adapter.There was no patient involvement; thus, no deaths, injuries, or surgical delays were reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The device cryosolutions 4pk cartrge (33517) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned cryosolutions cartridges were in used condition with no visible defects.Per visual and functional evaluation, two cartridges were full and functioned properly when attached to a test 33510 set.The issue of leaking during installation may be the result of incomplete attachment to the pen unit or a damaged o-ring inside the pen unit.Per the ifu, cryosolifu, "screw the cartridge into the control mechanism in a clockwise direction both quickly and completely to ensure proper functionality.Small amounts of gas escaping from the cartridge while being attached indicate poor alignment of the cartridge to the control mechanism." the issue of gas escaping, with no hazardous situation of "unintended cold applier to patient/user" occurring, is accounted for with the negligible risk line " device does not function as intended." root cause analysis: the reported complaint could not be duplicated.The returned 33517 cartridges are in used condition with no visible defects.Two cartridges were empty, and the other two functioned properly.This issue may be the result of incomplete attachment of the cartridge or damage to the pens' o-ring.
Event or Problem Description
N/a.

• Brand Name: CRYOSOLUTIONS 4PK 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: 22575591
• Report Number: 3014334038-2025-00105
• Device Sequence Number: 21257645
• Product Code: GEH
• UDI-Device Identifier: 10381780171966
• UDI-Public: 10381780171966
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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): 08/01/2025

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: 33517
• Device Lot Number: B0947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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