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	07/30/2025
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) was not working.It was reported that when they tried to attach a new canister, it sprayed out through the small holes in the thread.There was no patient involvement; thus, no patient injury, death, or surgical delay occurred.
Additional Manufacturer Narrative
Corrected field: the should description to reflect that the device was evaluated.Updated fields: d9, g6, h2.
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 returned for evaluation: the device history record (dhr) for this product was not available.The product serial number indicates a manufacturing date of 2010.Failure analysis: the received product was in used condition.Per the product repair, the unit required a replacement o-ring.The product serial number indicates a manufacture date of 2010.Damage or wear to the o-ring can lead to issues with spraying or leaking.The use of cartridges involved in a safety advisory reported by the product's manufacturer may also result in the reported issue.The lot of the cartridges used in this incident was not available for confirmation.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the reported complaint could not be confirmed.The returned 33510 cryosolutions set is in used condition with a new o-ring required.Damage to the o-ring may result in the reported issue.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Correction: root cause analysis: the returned 33510 cryosolutions set was in used condition with a new o-ring required.Damage to the o-ring may result in the reported issue.The reported complaint was confirmed.
Event or Problem Description
N/a.

• 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: 22849878
• Report Number: 3014334038-2025-00116
• Device Sequence Number: 4362084
• 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,Followup
• Report Date (Section B): 01/28/2026

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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 09/24/2025; 01/13/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/24/2025; 09/24/2025; 01/28/2026
• 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