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	Cryogenic Burn (4539)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
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 (33510) glass tip exploded while in use during wart cryotherapy.The physician sustained mild chemical surface burn while using the product.The procedure was stopped immediately and was not resumed.It was reported that the physician's burns are healing.No patient injury was reported.
Additional Manufacturer Narrative
The cryosolutions set with 1 cartridge (33510) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual/functional evaluation found that the cryosolutions set was returned in used condition with the glass tip broken.The gas cartridge functioned without issue when used with a test tip.The broken tip was also functional when used with a test gas cartridge.Root cause analysis: the reported complaint was confirmed.The issue of the tip "exploding" may be the result of the tip being damaged prior to use from an impact such as being dropped, then having its broken pieces pop off due to the gas pressure.Per the instruction for use (ifu), "always wear gloves when using cryosolutions devices.Before each use, ensure that the cryosolutions unit is not damaged and is operating properly." no manufacturing, workmanship, or material deficiency has been identified.Corrective and preventative action was opened to investigate the issue of providers being burned by cryosolutions.

• 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: 18650505
• Report Number: 3014334038-2024-00012
• Device Sequence Number: 12576648
• 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): 03/20/2024

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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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