BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEGA

    MDR report key: 23881576 · Received December 23, 2025

    Report

    Report Number
    MW5181107
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 11, 2025
    Report Date
    February 16, 2026
    Manufacturer
    CRYO CONCEPTS LP
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 2/17/2026 FOR REPORT MW5181107. SUMMARY OF COMPLAINT: PER THE (B)(4) SUBMITTED ON 12/18/2025, ¿PHYSICIAN WENT TO UTILIZE CRYOPEN. UPON ATTEMPTING TO USE PEN, PEN COMPLETELY DISCHARGED AT BUTTON THAT CONTROLS NITROGEN RELEASE. CRYOPEN MALFUNCTION, RELEASE ALL OF THE NITROUS OXIDE OUT OF DEVICE TRIGGER INSTEAD OF TIP/BARREL. NO HARM TO PATIENT OR PHYSICIAN. PEN WAS NEW, WITHIN MANUFACTURES EXPIRATION DATE. ECN: 160-2002. FDA REPORTED 12/18/2025.¿ PICTURES WERE NOT INCLUDED WITH THIS (B)(4). FINDINGS OF THE INVESTIGATION: THIS COMPLAINT WAS SUSTAINED AS CATEGORY II. IN ADDITION TO THE ABOVE SUMMARY, A MEDWATCH REPORT (FDA FORM 3500) OF THIS PRODUCT WAS SUBMITTED, WHICH PROVIDED MORE INFORMATION ON THE DEFICIENCY AND ACTIONS TAKEN AFTER IT WAS DISCOVERED (APPENDIX A). THE FDA FORM 3500 STATED THE FOLLOWING, ¿A PHYSICIAN WENT TO UTILIZE THE CRYOPEN. UPON ATTEMPTING TO USE THE PEN, THE PEN COMPLETELY DISCHARGED AT BUTTON THAT CONTROLS NITROGEN RELEASE. CRYOPEN MALFUNCTION AND RELEASE ALL THE NITROUS OXIDE GAS OUT OF THE DEVICE TRIGGER INSTEAD OF TIP/BARREL. NO HARM TO PATIENT OR (THE) PHYSICIAN. PEN (THE CRYOSURGICAL CRYOMEGA) WAS NEW, WITHIN MANUFACTURER EXPIRATION DATE: ITEM ID: 160-2002¿. MR. (B)(6) CONTACTED MS. (B)(6) AT (B)(6) MEDICAL CENTER ON (B)(6) 2026 AND REQUESTED ADDITIONAL INFORMATION IN REFERENCE TO COMMUNICATION WITH THE VENDOR AND A CASE COMPLAINT INVESTIGATION INITIATED BY THE VENDOR. ON (B)(6) 2026, MS. (B)(6) RESPONDED BACK AND COMMUNICATED AN FDA FORM 3500 HAD BEEN SUBMITTED WITH THE INITIAL (B)(4) AND AN EMAIL HAD BEEN SENT TO THE VENDOR ABOUT THE DEFICIENT ITEM. MS. (B)(6) ALSO REPORTED THAT SHE RECEIVED A NOTIFICATION FROM THE VENDOR (CRYO CONCEPTS LP), WHICH STATED THAT THE VENDOR PROCESSES COMPLAINTS THROUGH EMAIL ONLY. HOWEVER, THE VENDOR DECLINED TO PROVIDE MS. (B)(6) WITH A COMPLAINT NUMBER AS OF 1/12/2026. AN EMAIL WAS SENT FROM DLA ON 1/14/2026, TO CRYO CONCEPTS LP REQUESTING A CASE COMPLAINT NUMBER BE PROVIDED. CRYO CONCEPTS LP PROVIDED A CASE COMPLAINT NUMBER OF CRYOCONCEPTS #(B)(4) ON 1/14/2026. ACTION TAKEN TO CORRECT EXISTING DEFICIENCY: A REVIEW OF MAUDE REPORTS FROM THE PAST FIVE YEARS REVEALED NO INCIDENTS IN REFERENCE TO THIS ITEM. A REVIEW OF PQDRS FROM THE PAST FIVE YEARS REVEALED NO INSTANCES OF SIMILAR ISSUES WITH THIS PRODUCT. THERE ARE NO CURRENT ECRI OR MMQC MESSAGE REGARDING THIS PRODUCT. ACTION TAKEN TO PRECLUDE RECURRENCE: CONTINUE TO MONITOR YOUR ENVIRONMENT FOR DEFICIENCIES WITH THIS ITEM. RECOMMEND THE DEPARTMENT OF LOGISTICS SUBMIT A CASE COMPLAINT WITH THE VENDOR TO START AN INVESTIGATION INTO THE DEFICIENCY. RECOMMEND THE DEPARTMENT OF LOGISTICS REQUEST A REFUND OR REPLACEMENT FOR THE DEFICIENT ITEM FOLLOWING A COMPLETED VENDOR INVESTIGATION INTO THE PRODUCT DEFICIENCY INCIDENT.

    Description of Event or Problem · 0

    A PHYSICIAN WENT TO UTILIZE THE CRYPEN. UPON ATTEMPTING TO USE THE PEN, THE PEN COMPLETELY DISCHARGED AT BUTTON THAT CONTROLS NITROGEN RELEASE. CRYOPEN MALFUNCTION AND RELEASE ALL THE NITROUS OXIDE GAS OUT OF THE DEVICE TRIGGER INSTEAD OF TIP/BARREL. NO HARM TO PATIENT OR PHYSICIAN. PEN WAS NEW, WITHIN MANUFACTURER EXPIRATION DATE: ITEM ID: 160-2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647329 CRYOMEGA UNIT, CRYOSURGICAL, ACCESSORIES GEH CRYO CONCEPTS LP 160-2002 EO492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown