MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 10PK CARTRG; M3

Catalog Number	33516
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was attempting to attach a new cartridge/cryosolutions 10pk cartridge (33516) to the pen and it "exploded" with liquid nitrogen.It sprayed both of the physician's hand resulting in the physician getting minor burns on her hands before she could safely put it down.The entire pen and cartridge became covered in frost.It is unknown whether medical intervention was required.No patient injury or surgical delay has been 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.
Additional Manufacturer Narrative
Additional b5 narrative: it was reported "device/cartridges were not being used during surgery but for wart destruction.No patient was injured.One of the physician's got mild burns on hands.She was applying a new cartridge to cryopen (something she is very familiar doing) and the cartridge starting spraying uncontrollably, causing the cartridge and entire pen to become frozen white and covered in frost.When she was trying to put the pen down safely, her hand came in contact with the very cold units and she mildly burned her hands.She did not require any treatment for the exposure.".
Event or Problem Description
See h10.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), d9, h2, h3, h4, h6, h10.The suspected cartridge/cryosolutions 10pk cartridge (33516) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.Device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.The issue of gas exploding or spraying out may result from misalignment of the cartridge and control mechanism during setup.The instructions for use (ifu) directs user to always use protective gloves when installing cartridges and using cryosolutions® devices.The cartridge must be screwed into the control mechanism in a clockwise direction both quickly and completely.The pin must be fully inserted into the pin insertion point before attaching the cartridge.A definitive root cause cannot be determined.If additional relevant information becomes available, complaint will be reopened, and the respective evaluation performed.Rends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CRYOSOLUTIONS 10PK CARTRG
• Common Device Name: M3
• 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 ; 6099362319
• MDR Report Key: 18531860
• Report Number: 3014334038-2024-00009
• Device Sequence Number: 7772894
• Product Code: GEH
• UDI-Device Identifier: 10381780171959
• UDI-Public: 10381780171959
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2024

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: 33516
• Device Lot Number: A7663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 03/19/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/09/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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: Female