MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP; M3-DERMAL

Catalog Number	33510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 set with 1 cartridge/1mm tip (33510) leaked when it was attached to the canister.The issue occurred after a treatment.There was no patient involvement; therefore, no injuries, deaths, or surgical delays were reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The cryosolutions set with 1 cartridge/1mm tip (33510) was not returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.The 33510 cryosolutions set with 1 cartridge was not returned for evaluation after three good faith attempts (gfes) were made.As a result, the exact root cause of the reported issue could not be determined.The issue of leaking may be the result of a damaged o-ring, or overfilled cartridges related to a safety advisory from the product's manufacturer.Additional investigation by the product legal manufacturer/sales entity found that this lot of cartridges was affected by a valve that may open prematurely.The legal manufacturer has provided a safety advisory and updated instructions for use (ifu), which have been distributed by integra to affected customers/distributors as part of a voluntary correction.This customer may have received cartridges impacted by the safety advisory.If additional relevant information becomes available in the future, this complaint will be reopened, and an evaluation will be conducted.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The device 33510 cryosolutions set was returned for evaluation.Failure analysis: the returned 33510 cryosolutions set is in used condition with no visible defect.When the cartridge was attached to the pen body, gas could be heard passively escaping.The pen sputtered and did not spray continuously when used.When submerged in water, gas/bubbles could be seen escaping from the body, indicating a damaged, worn, or failing o-ring.Passive leaking is of negligible risk.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the reported complaint was confirmed.The pen was unable to spray continuously and was passively leaking due to a damaged o-ring.

• Brand Name: CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP
• Common Device Name: M3-DERMAL
• 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: 22440255
• Report Number: 3014334038-2025-00098
• Device Sequence Number: 19981780
• Product Code: GEH
• UDI-Device Identifier: 10381780171898
• UDI-Public: 10381780171898
• 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,Followup
• Report Date (Section B): 08/20/2025

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: 33510
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 08/04/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/20/2025
• 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