MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP; M3-DERMAL

Catalog Number	33510
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports for the cryosolutions set/pen used during this event and is linked to mfg number 3014334038-2024-00020.It was reported that a physician was burned when handling the cryosolutions set with 1 cartridge/1mm tip (33510).Staff was using a new lot of cartridges and one exploded with liquid nitrogen when applying a new cartridge to the cryopen.The reporter stated "maybe it is the pen".It is currently 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
Updated fields: d4 (product serial number, udi #), d9, g3, g6, h2, h3, h4, h6, h10.The suspected cryosolutions set with 1 cartridge/1mm tip (33510) was returned for evaluation: device history record (dhr) shows no abnormalities related to the reported issue were identified.Failure analysis - the cryosolutions pen of the cryosolutions set (33510) was received in used condition with a damaged o-ring, requiring replacement.A worn o-ring was replaced by the product repair technician to restore product functionality.The product serial number indicates a manufacture date of 2016.Wear or damage to the o-ring may have occurred over multiple years of use.Per the product supplier, a damaged poorly seated o-ring may allow gas to escape when installing a new cartridge.Protective gloves must always be worn when handling cryosolutions products.The instructions for use (ifu), directs user to "always use protective gloves when installing cartridges.Inspect cartridge for o-ring.If o-ring is missing, do not attach the cartridge.Contact integra miltex for o-ring replacement." root cause analysis: the reported complaint was confirmed.The issue of gas exploding or spraying out may result from installing a new cartridge with a damaged o-ring.Ifu states: "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".No manufacturing, workmanship, or material deficiency has been identified.
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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18727446
• Report Number: 3014334038-2024-00032
• Device Sequence Number: 17577995
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• 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