ICEFORCE 2.1 CX 90 DEGREE NEEDLE
Report
- Report Number
- 2134265-2022-02334
- Event Type
- Death
- Date Received
- March 2, 2022
- Date of Event
- February 9, 2022
- Report Date
- March 16, 2023
- Manufacturer
- BTG YOKNEAM
- Product Code
- GEH
- UDI-DI
- 07290104831003
- PMA / PMN Number
- K152133
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AGE AT TIME OF EVENT: PATIENT IN THEIR 70S.
AGE AT TIME OF EVENT - PATIENT IN THEIR 70S. ADDITIONAL INFORMATION ADDED TO: H6: PATIENT CODES. REPORTED MEDWATCH # 0039-0111-2022-0002.
REPORTED MEDWATCH # (B)(4). ADDITIONAL INFORMATION ADDED TO: A. PATIENT INFORMATION. B5: DESCRIBE EVENT OR PROBLEM. B7: OTHER RELEVANT HISTORY.
REPORTED MEDWATCH # (B)(4). DEVICE EVALUATION: REVIEW OF ALL AVAILABLE INFORMATION, INCLUDING RETURNED DEVICE ANALYSIS, FOUND NO EVIDENCE TO INDICATE THAT THE REPORTED EVENT WAS DUE TO A DEVICE DESIGN- OR MANUFACTURING-RELATED CAUSE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ASSOCIATED LOT (U3555) CONFIRMED THAT ALL DEVICES IN THIS LOT MET SPECIFICATION PRIOR TO DISTRIBUTION, AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED ASSOCIATED WITH THIS LOT. FOUR (4) 2.1 CX ICEFORCE NEEDLE SHAFTS AND FOUR (4) CRYOABLATION NEEDLE CABLES WITH THE AFOREMENTIONED SHAFTS SEPARATED AT THE SHAFT-HANDLE CONNECTION WERE RETURNED FOR ANALYSIS. THE FOUR RETURNED NEEDLE SHAFTS WERE LABELED BY THE USER FACILITY AS A, B, C, AND D. THE FOUR RETURNED NEEDLE CABLES WERE LABELED BY THE USER FACILITY AS 1, 2, 3, AND 4. THE FOUR RETURNED CRYOABLATION NEEDLE CABLES WERE PLUGGED INTO THE IN-HOUSE CRYOABLATION CONSOLE, AND EACH LOT NUMBER WAS VERIFIED AND CONSISTED OF U3555, U3555, U3470, AND U3360. THESE LOT NUMBERS MATCHED THE RETURNED NEEDLE PACKAGING. PAIRING OF THE INDIVIDUAL SHAFTS TO A LOT NUMBER WAS NOT POSSIBLE DUE TO THE SEPARATION OF THE CABLE. THIS ANALYSIS IS FOR THE 2.1 CX ICEFORCE NEEDLE SHAFT THAT WAS RETURNED WITH AN A AND THE CABLE RETURNED WITH A 4. THE CABLE WAS VISUALLY INSPECTED WITH NO OBVIOUS DAMAGE OBSERVED. THE NEEDLE SHAFT WAS SEPARATED FROM THE CABLE AT THE HANDLE-SHAFT JUNCTION. THE NEEDLE SHAFT WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE PROXIMAL SEPARATED END OF THE NEEDLE SHAFT HAD INDENTATION DAMAGE AND WAS PINCHED CLOSED. SCRATCHES WERE NOTED ON THE SURFACE THROUGHOUT THE SHAFT OF THE NEEDLE. SCRAPES THAT REMOVED SOME OF THE BLACK COATING WERE SEEN ON THE BLACK MARKER RINGS AND THE TREATMENT ZONE. THE TIP OF THE NEEDLE WAS SLIGHTLY BLUNTED. A SHAFT LEAK TEST OF THE REFERENCED NEEDLE WAS PERFORMED. SINCE THE NEEDLE SHAFT WAS SEPARATED FROM THE NEEDLE HANDLE, CONNECTING THE NEEDLE TO THE CONSOLE FOR TESTING WAS NOT POSSIBLE. PLYERS WERE USED TO OPEN THE CRIMPED PROXIMAL END OF THE NEEDLE SHAFT WHERE THE NEEDLE SHAFT HAD BEEN SEPARATED FROM THE NEEDLE HANDLE. THE NEEDLE SHAFT WAS INSERTED INTO A FIXTURE THAT ALLOWS AIR TO BE INTRODUCED INTO THE SHAFT IN A SEALED ENVIRONMENT. THE NEEDLE SHAFT WAS THEN SUBMERGED INTO A WATER BATH AND AIR WAS INTRODUCED INTO THE NEEDLE SHAFT WITH THE INTENTION OF OBSERVING ANY AIR BUBBLES THAT MAY PRESENT THEMSELVES FROM THE NEEDLE SHAFT. AIR WAS APPLIED TO THE NEEDLE SHAFT USING 20 CC, 10 CC, AND 3 CC SYRINGES, AND COMPRESSED AIR. NO BUBBLES WERE OBSERVED DURING ANY OF THE AIR SOURCE TESTS, CONFIRMING THAT THE NEEDLE SHAFT WAS PATENT WITHOUT ANY INDICATIONS OF HOLES IN THE NEEDLE SHAFT THAT COULD CONTRIBUTE TO A LEAK.
AGE AT TIME OF EVENT - PATIENT IN THEIR 70S.
IT WAS REPORTED A SHAFT LEAK OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. FOUR ICEFORCE NEEDLES WERE SELECTED FOR USE IN A CRYOABLATION TREATMENT PROCEDURE IN A 4-CENTIMETER TUMOR LOCATED IN THE PERIPHERAL PORTION OF THE RIGHT LUNG. THE PATIENT WAS GETTING SINGLE LUNG VENTILATION ON THE LEFT SIDE DUE TO THE HIGH RISK FOR PNEUMOTHORAX GIVEN PREEXISTING IDIOPATHIC PULMONARY FIBROSIS (IPF). ALL FOUR NEEDLES WERE TESTED SUCCESSFULLY BEFORE BEING INSERTED INTO THE PATIENT. THE NEEDLES WERE PLACED INTO THE TUMOR WITHOUT INCIDENT. THE FIRST FREEZE CYCLE WAS INITIATED, FOR FIVE MINUTES, FOLLOWED BY A PASSIVE THAW AND COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT INCIDENT. A SECOND FREEZE CYCLE WAS STARTED, BUT NINE MINUTES INTO THE FREEZE-THAW CYCLE, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTICED A CHANGE IN THE WAVEFORM, A SUDDEN DROP IN THE PATIENTS' BLOOD PRESSURE, AND CARDIOPULMONARY COLLAPSE. CT SCAN WAS PERFORMED IMMEDIATELY SHOWING SUDDEN CARDIAC PULMONARY COLLAPSE, A LARGE PNEUMOTHORAX ON THE RIGHT, EXTENSIVE MEDIASTINAL GAS, DISSECTED INTO THE PATIENTS' ABDOMEN. SIZABLE AIR-FLUID LEVELS WITHIN THE AORTA WERE PRESENT, INDICATING LARGE GAS FORCE THRU THE PULMONARY VEINS, PROBABLY INTO THE HEART THAT CAME AROUND TO CORONARY ARTERIES WHICH CAUSED THE PATIENT'S INSTANTANEOUS CARDIOPULMONARY COLLAPSE. THE NEEDLES WERE REMOVED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED FOR APPROXIMATELY FIVE MINUTES BEFORE CIRCULATION RETURNED. THE PATIENT DEVELOPED BILATERAL PNEUMOTHORACES FROM CPR, BILATERAL CHEST TUBES WERE PLACED AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) TO BE MONITORED AND TREATED. THE PATIENT WAS REPORTED AS HAVING NO RETURN OF MENTAL FUNCTION. FIFTEEN DAYS LATER THE PATIENTS' CONDITION WAS REPORTED AS: "RETURN OF NEUROLOGIC FUNCTION, AWAKE ALERT EXTUBATED, HOWEVER PERSISTENT BRONCHOPLEURAL FISTULA AND REQUIRES HI-FLOW OXYGEN, THE PATIENT ALSO HAS SIGNIFICANT PULMONARY HYPERTENSION, WHICH IS NEW." ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING DEVICE RETURN, BUT HAS NOT BEEN RECEIVED FROM THE HEALTH CARE FACILITY AT THIS TIME.
IT WAS REPORTED A SHAFT LEAK OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. FOUR ICEFORCE NEEDLES WERE SELECTED FOR USE IN A CRYOABLATION TREATMENT PROCEDURE IN A 4-CENTIMETER TUMOR LOCATED IN THE PERIPHERAL PORTION OF THE RIGHT LUNG. THE PATIENT WAS GETTING SINGLE LUNG VENTILATION ON THE LEFT SIDE DUE TO THE HIGH RISK FOR PNEUMOTHORAX GIVEN PREEXISTING IDIOPATHIC PULMONARY FIBROSIS (IPF). ALL FOUR NEEDLES WERE TESTED SUCCESSFULLY BEFORE BEING INSERTED INTO THE PATIENT. THE NEEDLES WERE PLACED INTO THE TUMOR WITHOUT INCIDENT. THE FIRST FREEZE CYCLE WAS INITIATED, FOR FIVE MINUTES, FOLLOWED BY A PASSIVE THAW AND COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT INCIDENT. A SECOND FREEZE CYCLE WAS STARTED, BUT NINE MINUTES INTO THE FREEZE-THAW CYCLE, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTICED A CHANGE IN THE WAVEFORM, A SUDDEN DROP IN THE PATIENTS' BLOOD PRESSURE, AND CARDIOPULMONARY COLLAPSE. CT SCAN WAS PERFORMED IMMEDIATELY SHOWING SUDDEN CARDIAC PULMONARY COLLAPSE, A LARGE PNEUMOTHORAX ON THE RIGHT, EXTENSIVE MEDIASTINAL GAS, DISSECTED INTO THE PATIENTS' ABDOMEN. SIZABLE AIR-FLUID LEVELS WITHIN THE AORTA WERE PRESENT, INDICATING LARGE GAS FORCE THRU THE PULMONARY VEINS, PROBABLY INTO THE HEART THAT CAME AROUND TO CORONARY ARTERIES WHICH CAUSED THE PATIENT'S INSTANTANEOUS CARDIOPULMONARY COLLAPSE. THE NEEDLES WERE REMOVED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED FOR APPROXIMATELY FIVE MINUTES BEFORE CIRCULATION RETURNED. THE PATIENT DEVELOPED BILATERAL PNEUMOTHORACES FROM CPR, BILATERAL CHEST TUBES WERE PLACED AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) TO BE MONITORED AND TREATED. THE PATIENT WAS REPORTED AS HAVING NO RETURN OF MENTAL FUNCTION. FIFTEEN DAYS LATER THE PATIENTS' CONDITION WAS REPORTED AS: "RETURN OF NEUROLOGIC FUNCTION, AWAKE ALERT EXTUBATED, HOWEVER PERSISTENT BRONCHOPLEURAL FISTULA AND REQUIRES HI-FLOW OXYGEN, THE PATIENT ALSO HAS SIGNIFICANT PULMONARY HYPERTENSION, WHICH IS NEW." IT WAS FURTHER REPORTED THE THE PATIENT WAS UNABLE TO GET THE BRONCHOPLEURAL FISTULA (BPF) TREATED DUE TO TENUOUS RESPIRATORY STATUS, AND THE PATIENT AND FAMILY WERE NOT INTERESTED IN RE-INTUBATION, SO WAS MADE COMFORT CARE, AND PASSED AWAY ON THE (B)(6) 2022. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING DEVICE RETURN, BUT HAS NOT BEEN RECEIVED FROM THE HEALTH CARE FACILITY AT THIS TIME.
IT WAS REPORTED A SHAFT LEAK OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. FOUR ICEFORCE NEEDLES WERE SELECTED FOR USE IN A CRYOABLATION TREATMENT PROCEDURE IN A 4-CENTIMETER TUMOR LOCATED IN THE PERIPHERAL PORTION OF THE RIGHT LUNG. THE PATIENT WAS GETTING SINGLE LUNG VENTILATION ON THE LEFT SIDE DUE TO THE HIGH RISK FOR PNEUMOTHORAX GIVEN PREEXISTING IDIOPATHIC PULMONARY FIBROSIS (IPF). ALL FOUR NEEDLES WERE TESTED SUCCESSFULLY BEFORE BEING INSERTED INTO THE PATIENT. THE NEEDLES WERE PLACED INTO THE TUMOR WITHOUT INCIDENT. THE FIRST FREEZE CYCLE WAS INITIATED, FOR FIVE MINUTES, FOLLOWED BY A PASSIVE THAW AND COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT INCIDENT. A SECOND FREEZE CYCLE WAS STARTED, BUT NINE MINUTES INTO THE FREEZE-THAW CYCLE, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTICED A CHANGE IN THE WAVEFORM, A SUDDEN DROP IN THE PATIENTS' BLOOD PRESSURE, AND CARDIOPULMONARY COLLAPSE. CT SCAN WAS PERFORMED IMMEDIATELY SHOWING SUDDEN CARDIAC PULMONARY COLLAPSE, A LARGE PNEUMOTHORAX ON THE RIGHT, EXTENSIVE MEDIASTINAL GAS, DISSECTED INTO THE PATIENTS' ABDOMEN. SIZABLE AIR-FLUID LEVELS WITHIN THE AORTA WERE PRESENT, INDICATING LARGE GAS FORCE THRU THE PULMONARY VEINS, PROBABLY INTO THE HEART THAT CAME AROUND TO CORONARY ARTERIES WHICH CAUSED THE PATIENT'S INSTANTANEOUS CARDIOPULMONARY COLLAPSE. THE NEEDLES WERE REMOVED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED FOR APPROXIMATELY FIVE MINUTES BEFORE CIRCULATION RETURNED. THE PATIENT DEVELOPED BILATERAL PNEUMOTHORACES FROM CPR, BILATERAL CHEST TUBES WERE PLACED AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) TO BE MONITORED AND TREATED. THE PATIENT WAS REPORTED AS HAVING NO RETURN OF MENTAL FUNCTION. FIFTEEN DAYS LATER THE PATIENTS' CONDITION WAS REPORTED AS: "RETURN OF NEUROLOGIC FUNCTION, AWAKE ALERT EXTUBATED, HOWEVER PERSISTENT BRONCHOPLEURAL FISTULA AND REQUIRES HI-FLOW OXYGEN, THE PATIENT ALSO HAS SIGNIFICANT PULMONARY HYPERTENSION, WHICH IS NEW." THE PATIENT WAS UNABLE TO GET THE BRONCHOPLEURAL FISTULA (BPF) TREATED DUE TO TENUOUS RESPIRATORY STATUS, AND THE PATIENT AND FAMILY WERE NOT INTERESTED IN RE-INTUBATION, SO WAS MADE COMFORT CARE, AND PASSED AWAY ON THE (B)(6), 2022. IT WAS FURTHER REPORTED THAT THE FAST THAW FUNCTION WAS USED TO QUICKLY REMOVE THE PROBES DURING THE PROCEDURE. THE CAUSE OF DEATH WAS CARDIAC ARREST CAUSED BY HYPOXIA DUE TO PERSISTENT BRONCHOPLEURAL FISTULA, IN THE SETTING OF ADVANCED INTERSTITIAL LUNG DISEASE AND LUNG CANCER.
IT WAS REPORTED A SHAFT LEAK OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. FOUR ICEFORCE NEEDLES WERE SELECTED FOR USE IN A CRYOABLATION TREATMENT PROCEDURE IN A 4-CENTIMETER TUMOR LOCATED IN THE PERIPHERAL PORTION OF THE RIGHT LUNG. THE PATIENT WAS GETTING SINGLE LUNG VENTILATION ON THE LEFT SIDE DUE TO THE HIGH RISK FOR PNEUMOTHORAX GIVEN PREEXISTING IDIOPATHIC PULMONARY FIBROSIS (IPF). ALL FOUR NEEDLES WERE TESTED SUCCESSFULLY BEFORE BEING INSERTED INTO THE PATIENT. THE NEEDLES WERE PLACED INTO THE TUMOR WITHOUT INCIDENT. THE FIRST FREEZE CYCLE WAS INITIATED, FOR FIVE MINUTES, FOLLOWED BY A PASSIVE THAW AND COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT INCIDENT. A SECOND FREEZE CYCLE WAS STARTED, BUT NINE MINUTES INTO THE FREEZE-THAW CYCLE, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTICED A CHANGE IN THE WAVEFORM, A SUDDEN DROP IN THE PATIENTS' BLOOD PRESSURE, AND CARDIOPULMONARY COLLAPSE. CT SCAN WAS PERFORMED IMMEDIATELY SHOWING SUDDEN CARDIAC PULMONARY COLLAPSE, A LARGE PNEUMOTHORAX ON THE RIGHT, EXTENSIVE MEDIASTINAL GAS, DISSECTED INTO THE PATIENTS' ABDOMEN. SIZABLE AIR-FLUID LEVELS WITHIN THE AORTA WERE PRESENT, INDICATING LARGE GAS FORCE THRU THE PULMONARY VEINS, PROBABLY INTO THE HEART THAT CAME AROUND TO CORONARY ARTERIES WHICH CAUSED THE PATIENT'S INSTANTANEOUS CARDIOPULMONARY COLLAPSE. THE NEEDLES WERE REMOVED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED FOR APPROXIMATELY FIVE MINUTES BEFORE CIRCULATION RETURNED. THE PATIENT DEVELOPED BILATERAL PNEUMOTHORACES FROM CPR, BILATERAL CHEST TUBES WERE PLACED AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) TO BE MONITORED AND TREATED. THE PATIENT WAS REPORTED AS HAVING NO RETURN OF MENTAL FUNCTION. FIFTEEN DAYS LATER THE PATIENTS' CONDITION WAS REPORTED AS: "RETURN OF NEUROLOGIC FUNCTION, AWAKE ALERT EXTUBATED, HOWEVER PERSISTENT BRONCHOPLEURAL FISTULA AND REQUIRES HI-FLOW OXYGEN, THE PATIENT ALSO HAS SIGNIFICANT PULMONARY HYPERTENSION, WHICH IS NEW." IT WAS FURTHER REPORTED THE PATIENT WAS UNABLE TO GET THE BRONCHOPLEURAL FISTULA (BPF) TREATED DUE TO TENUOUS RESPIRATORY STATUS, AND THE PATIENT AND FAMILY WERE NOT INTERESTED IN RE-INTUBATION, SO WAS MADE COMFORT CARE, AND PASSED AWAY ON THE (B)(6) 2022. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING DEVICE RETURN, BUT HAS NOT BEEN RECEIVED FROM THE HEALTH CARE FACILITY AT THIS TIME.
IT WAS REPORTED A SHAFT LEAK OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. FOUR ICEFORCE NEEDLES WERE SELECTED FOR USE IN A CRYOABLATION TREATMENT PROCEDURE IN A 4-CENTIMETER TUMOR LOCATED IN THE PERIPHERAL PORTION OF THE RIGHT LUNG. THE PATIENT WAS GETTING SINGLE LUNG VENTILATION ON THE LEFT SIDE DUE TO THE HIGH RISK FOR PNEUMOTHORAX GIVEN PREEXISTING IDIOPATHIC PULMONARY FIBROSIS (IPF). ALL FOUR NEEDLES WERE TESTED SUCCESSFULLY BEFORE BEING INSERTED INTO THE PATIENT. THE NEEDLES WERE PLACED INTO THE TUMOR WITHOUT INCIDENT. THE FIRST FREEZE CYCLE WAS INITIATED, FOR FIVE MINUTES, FOLLOWED BY A PASSIVE THAW AND COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT INCIDENT. A SECOND FREEZE CYCLE WAS STARTED, BUT NINE MINUTES INTO THE FREEZE-THAW CYCLE, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) NOTICED A CHANGE IN THE WAVEFORM, A SUDDEN DROP IN THE PATIENTS' BLOOD PRESSURE, AND CARDIOPULMONARY COLLAPSE. CT SCAN WAS PERFORMED IMMEDIATELY SHOWING SUDDEN CARDIAC PULMONARY COLLAPSE, A LARGE PNEUMOTHORAX ON THE RIGHT, EXTENSIVE MEDIASTINAL GAS, DISSECTED INTO THE PATIENTS' ABDOMEN. SIZABLE AIR-FLUID LEVELS WITHIN THE AORTA WERE PRESENT, INDICATING LARGE GAS FORCE THRU THE PULMONARY VEINS, PROBABLY INTO THE HEART THAT CAME AROUND TO CORONARY ARTERIES WHICH CAUSED THE PATIENT'S INSTANTANEOUS CARDIOPULMONARY COLLAPSE. THE NEEDLES WERE REMOVED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED FOR APPROXIMATELY FIVE MINUTES BEFORE CIRCULATION RETURNED. THE PATIENT DEVELOPED BILATERAL PNEUMOTHORACES FROM CPR, BILATERAL CHEST TUBES WERE PLACED AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) TO BE MONITORED AND TREATED. THE PATIENT WAS REPORTED AS HAVING NO RETURN OF MENTAL FUNCTION. FIFTEEN DAYS LATER THE PATIENTS' CONDITION WAS REPORTED AS: "RETURN OF NEUROLOGIC FUNCTION, AWAKE ALERT EXTUBATED, HOWEVER PERSISTENT BRONCHOPLEURAL FISTULA AND REQUIRES HI-FLOW OXYGEN, THE PATIENT ALSO HAS SIGNIFICANT PULMONARY HYPERTENSION, WHICH IS NEW." IT WAS FURTHER REPORTED THE PATIENT WAS UNABLE TO GET THE BRONCHOPLEURAL FISTULA (BPF) TREATED DUE TO TENUOUS RESPIRATORY STATUS, AND THE PATIENT AND FAMILY WERE NOT INTERESTED IN RE-INTUBATION, SO WAS MADE COMFORT CARE, AND PASSED AWAY ON THE (B)(6) 2022. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING DEVICE RETURN, BUT HAS NOT BEEN RECEIVED FROM THE HEALTH CARE FACILITY AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1168341 | ICEFORCE 2.1 CX 90 DEGREE NEEDLE | UNIT, CRYOSURGICAL, ACCESSORIES | GEH | BTG YOKNEAM | FPRPR3602 | U3555 | 07290104831003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Life Threatening| R| D |