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	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a procedure, the cryosolutions set with 1 cartridge/1mm tip (33510) was coming out from the side and was not funneling properly through the nozzle.There were no death, injuries, or surgical delays reported at this time.
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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h1, h2, h3, h6, h11.The 33510 cryosolutions set with 1 cartridge 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 set was in used condition.Evaluation identified debris inside the control mechanism near the o-ring.When connected to a cartridge and submerged in water, gas leaked out of the tip, indicating damage/wear to the o-ring.The issue of spraying improperly may be the result of a worn o-ring.The use of cartridges involved in a safety advisory reported by the product's legal manufacturer may also result in the reported issue.The lot number of the cartridges used in this incident was not available for confirmation.Root cause analysis: the reported complaint was confirmed.A damaged o-ring due to wear may lead to improper spraying.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: d9: device available for eval.

• 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: 22907311
• Report Number: 3014334038-2025-00121
• Device Sequence Number: 8814354
• 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): 12/01/2025

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: 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 12/01/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/01/2025
• 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