MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRYOSOLUTIONS 4PK CARTRGE; INSTRUMENTS - CRYO

Catalog Number	33517
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/19/2026
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 one of the employees had used the cryosolutions 4pk cartrge (33517), and it exploded in her hand and burned her hand.There was no patient involvement, and no death or surgical delay was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field - d9, g3, g6, h2, h3, h6, h11.The cryosolutions 4pk cartrge (33517) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history records (dhr) were reviewed, and no anomalies were found.The issue of "exploding" may refer to gas unexpectedly escaping from the tip.Gas can escape during cartridge installation as a result of damage to the applicator's o-ring or incomplete installation.For this reason, gloves and safety glasses must be used.Per the instruction for use (ifu), cryosolifu, " always use protective gloves and safety glasses when using cryosolutions® device, including when installing or removing cartridges." additionally, "screw the cartridge into the control mechanism in a clockwise direction both quickly and completely to ensure proper functionality." the root cause of the reported issue could not be determined.This can result from a damaged o-ring or an incomplete cartridge installation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.There is a recall for the product id 333517, but a different lot number was recalled.Therefore, we are including the correction/removal number for informational purposes only.

• Brand Name: CRYOSOLUTIONS 4PK CARTRGE
• Common Device Name: INSTRUMENTS - CRYO
• 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: 24606354
• Report Number: 3014334038-2026-00023
• Device Sequence Number: 13348121
• Product Code: GEH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 33517
• Device Lot Number: A7861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 96067
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown