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	Caustic/Chemical Burns (2549)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 2 of 2 for the cryo-pen used during this event and is linked to mfg number 3014334038-2024-00037: a facility reported that before a procedure, when the end user started screwing a cartridge onto the unspecified cryo-pen, gas spilled out and froze the user's hands.The user experienced redness and tenderness to hands.Observation of the user was performed.No further user outcome was reported.
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.E1: full name of reporting facility is (b)(6) clinic.
Additional Manufacturer Narrative
Corrected b5 narrative: a facility reported that before a procedure, when the end user started screwing a cartridge onto the cryosolution pen/ cryosolutions set with 1 cartridge/1mm tip (33510), gas spilled out and froze the user's hands.The user experienced redness and tenderness to hands.Observation of the user was performed.No further user outcome was reported.Updated h10 narrative: the suspected cryosolution pen/cryosolutions set with 1 cartridge/1mm tip (33510) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.A definitive root cause cannot be determined.Per the product supplier, a damaged poorly seated o-ring may allow gas to escape when installing a new cartridge.The product serial number indicates a manufacture date of 2018.Wear or damage to the o-ring may have occurred over multiple years of use.Gas can also escapee if a new cartridge is installed incompletely.The cartridge must be screwed in quickly and completely.Protective gloves must always be worn when handling cryosolutions products.Corrective and preventative action was opened to investigate the issue of providers being burned by cryosolutions.Trends will be monitored for this and similar issues.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: h1 (h1 of follow-up 1 was mistakenly reported as malfunction).

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18794053
• Report Number: 3014334038-2024-00041
• Device Sequence Number: 7331202
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/09/2024; 06/16/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/22/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2018
• 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