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

Catalog Number	33518
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when they attached the cryosolutions 1pk cartrge (33518) during a procedure, all of the air came out at once.No injuries, death, or surgical delay was reported.
Additional Manufacturer Narrative
The cryosolutions 1pk cartrge (33518) 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 33518 cryosolutions cartridge was in used condition with no visible defect.The cartridge was able to attach to a test pen and function properly.The issue of spraying may be the result of incomplete installation or a damaged o-ring on the pen control mechanism.Per the product instruction for use (ifu), cryosolifu, "care should be taken to align the cartridge and control mechanism so that gas does not inadvertently escape.Screw the cartridge into the control mechanism in a clockwise direction both quickly and completely to ensure proper functionality."the reported complaint could not be duplicated.The returned 33518 cartridge was able to attach and function properly.Root cause analysis: the reported complaint could not be duplicated.The returned 33518 cartridge was able to connect and function properly with a pen control mechanism.This complaint may be the result of incompletely attaching the cartridge or a damaged o-ring.No manufacturing, workmanship, or material deficiency has been identified.

• 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: 22770673
• Report Number: 3014334038-2025-00115
• Device Sequence Number: 18547112
• Product Code: GEH
• UDI-Device Identifier: 10381780171973
• UDI-Public: 10381780171973
• 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
• Report Date (Section B): 08/11/2025

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: 7510332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/11/2025
• 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