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	04/15/2024
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 during testing prior to surgery, the doctor tried to use the trigger mechanism of the cryosolutions set with 1 cartridge/1mm tip (33510), and the whole cartridge discharged.No injury or surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), d9, g3, g6, h2, h3, h6, h11.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.The product serial number indicates a manufacture date of 2012.The issue of discharging may be the result of a damaged or missing o-ring, or misalignment of the pen when installing a cartridge.Per the instructions for use (ifu), "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." however, without return of the the product, a definitive root cause of the reported issue 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.

• 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: 20266868
• Report Number: 3014334038-2024-00191
• Device Sequence Number: 19681508
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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