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	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cryosolutions set with 1 cartridge/1mm tip (33510) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Serial number was provided; manufacturing records were reviewed and no abnormalities related to the reported issue were identified.Per the provided images, the item had gouges on the control mechanism from using tools to overtighten the device.The product serial number indicates a manufacturer date of 2017.The issue of gas escaping may be the result of a damaged o-ring from overtightening with tools or wear.Per the product instructions for use (ifu), " pin must be fully inserted into the pin insertion point before attaching the cartridge.Cartridge must be aligned properly prior to assembly.Do not employ excessive force when connecting the cartridge to the control mechanism.Do not remove cartridge until empty.Center tip prior to screwing into place.Do not over-tighten".A safety advisory was previously initiated by the product legal for certain lots of cryosolutions cartridges.A lot of the cartridges used in this event was not provided.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that before a procedure was performed, the cartridge of the cryosolutions set with 1 cartridge/1mm tip (33510) was attached to the tip and gas leaked from the pen.When the cartridge was fully on and tight, the gas continued to leak out of the holes around the cartridge tip, even though the lever was not being pushed down.There was no patient involvement; thus, no injury, death or surgical delay was reported.

• 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: 22391718
• Report Number: 3014334038-2025-00092
• Device Sequence Number: 13056430
• Product Code: GEH
• UDI-Device Identifier: 10381780171898
• UDI-Public: 10381780171898
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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