GALAXY SYSTEM
Report
- Report Number
- 3021325287-2024-00008
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- June 12, 2024
- Report Date
- July 25, 2025
- Manufacturer
- NOAH MEDICAL CORP.
- Product Code
- EOQ
- PMA / PMN Number
- K223144
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2024, THE PATIENT WAS UNDERGOING A BIOPSY PROCEDURE FOR A 9MM LESION IN THE RIGHT LOWER LOBE. DURING THE PROCEDURE, BOTH WIRED CONTROLLERS USED WERE REPORTED TO HAVE BROKEN JOYSTICKS. AFTER THE 2ND CONTROLLER (SERIAL NUMBER (B)(6)) BROKE, THE SCOPE STARTED TO DRIFT SIGNIFICANTLY INTO THE RIGHT UPPER LOBE, AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO SYMPTOMS OR BLEEDING WERE REPORTED, AND NO TREATMENT WAS UNDERTAKEN. THE INVESTIGATION OF THE FIRST CONTROLLER USED IN THE INVESTIGATION ((B)(6)) DID NOT REVEAL ANY INJURY TO THE PATIENT, NOR WERE ANY SYMPTOMS OR INJURY REPORTED BY THE PHYSICIAN. THE RIGHT JOYSTICK FRACTURES AT THE JOYSTICK BOARD PCBA, HOWEVER IT STAYED ON THE POTENTIOMETER. THE INVESTIGATION OF THE RETURNED WIRED CONTROLLER (B)(6) IDENTIFIED ROOT CAUSE OF THE BREAKAGE AS A FAILURE OF THE JOYSTICK GLUE JOINT BETWEEN THE CAP AND THE POTENTIOMETER. THIS RESULTED IN THE JOYSTICK ASSEMBLY PULLING OUT THE POTENTIOMETER. REVIEW OF THE PROCEDURE VIDEO DURING RETURN PRODUCT INVESTIGATION REVEALED THAT SCOPE STARTED MOVING WITHOUT USER INPUT, FOLLOWED BY THE SCOPE TIP PUNCTURING THE AIRWAY TISSUE INTO THE PARENCHYMA (LUNG TISSUE). UNCONTROLLED SCOPE MOVEMENT CONTINUED FOR 23 SECONDS. THE UNINTENDED MOTION OF THE SCOPE WAS THE RESULT OF THE POTENTIOMETER COMING TO REST AFTER THE JOYSTICK BREAKAGE (OF (B)(6)) AT A STEADY OUTPUT VALUE THAT COMMANDED MOTION WITHOUT USER INPUT.
THE PATIENT WAS UNDERGOING A BIOPSY PROCEDURE FOR A 9MM LESION IN THE RIGHT LOWER LOBE. DURING THE PROCEDURE, BOTH WIRED CONTROLLERS USED WERE REPORTED TO HAVE BROKEN JOYSTICKS. AFTER THE 2ND CONTROLLER (SERIAL NUMBER (B)(6)) BROKE, THE SCOPE STARTED TO DRIFT SIGNIFICANTLY INTO THE RIGHT UPPER LOBE, AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO SYMPTOMS OR BLEEDING WERE REPORTED, AND NO TREATMENT WAS UNDERTAKEN. REVIEW OF THE PROCEDURE VIDEO DURING RETURN PRODUCT INVESTIGATION ON 03JUL2024 REVEALED THAT SCOPE STARTED MOVING WITHOUT USER INPUT, FOLLOWED BY THE SCOPE TIP PUNCTURING THE AIRWAY TISSUE INTO THE PARENCHYMA (LUNG TISSUE). A "SCOPE BUCKLING" MESSAGE ALSO APPEARED. UNCONTROLLED SCOPE MOVEMENT CONTINUED FOR 23 SECONDS. THE INVESTIGATION OF THE RETURNED WIRED CONTROLLER ((B)(6)) IDENTIFIED ROOT CAUSE OF THE BREAKAGE AS A FAILURE OF THE JOYSTICK GLUE JOINT BETWEEN THE CAP AND THE POTENTIOMETER. THIS RESULTED IN THE JOYSTICK ASSEMBLY PULLING OUT THE POTENTIOMETER. THE UNINTENDED MOTION OF THE SCOPE WAS THE RESULT OF THE POTENTIOMETER COMING TO REST AFTER THE JOYSTICK BREAKAGE (OF (B)(6)) AT A STEADY OUTPUT VALUE THAT COMMANDED MOTION WITHOUT USER INPUT. INVESTIGATION ACTIVITIES ALSO INCLUDED A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH WIRED CONTROLLER SERIAL NUMBER (B)(6). NO NON-CONFORMANCES OR DEVIATIONS ARE ASSOCIATED WITH THIS PRODUCT. THE INVESTIGATION OF THE FIRST CONTROLLER USED IN THE INVESTIGATION ((B)(6)) DID NOT REVEAL ANY INJURY TO THE PATIENT, NOR WERE ANY SYMPTOMS OR INJURY REPORTED BY THE PHYSICIAN. THE RIGHT JOYSTICK FRACTURES AT THE JOYSTICK BOARD PCBA, HOWEVER IT STAYED ON THE POTENTIOMETER. SUBMISSION #1: SUBMISSION FAILED. INITIAL ATTEMPT TO SUBMIT. SUBMISSION #2: ISSUING INIITIAL REPORT 3500A FORM TO CAPTURE REVISION OF MDR REPORT NUMBER. NO CHANGE IN MANUFACTURER'S NARRATIVE. HELPDESK ASSISTANCE PROVIDED TO ENSURE SUCCESSFUL SUBMISSION. FOLLOW UP #1: UPDATE B4: DATE OF REPORT. UPDATE D3: ESTABLISHMENT NAME: NOAH MEDICAL CORP. UPDATE D4: LOT#: 2024040806. UDI NUMBER: (B)(4). EXP DATE: 10/01/2024. UPDATE E-4: INITIAL REPORTER DETAILS WERE ADDED. UPDATE G1: ESTABLISHMENT NAME: NOAH MEDICAL CORP. UPDATE H1: TYPE OF REPORTABLE EVENT: MALFUNCTION. UPDATE H2: FOR CORRECTION AND ADDITIONAL INFORMATION. UPDATE H11: REDACTED DATE AND PER ORIGINAL INVESTIGATION THE RIGHT JOYSTICK WAS INCORRECTLY STATED. THE CORRECTED STATEMENT IS "THE LEFT JOYSTICK FRACTURES AT THE JOYSTICK BOARD PCBA, HOWEVER IT STAYED ON THE POTENTIOMETER.
ON (B)(6) 2024, THE PATIENT WAS UNDERGOING A BIOPSY PROCEDURE FOR A 9MM LESION IN THE RIGHT LOWER LOBE. DURING THE PROCEDURE, BOTH WIRED CONTROLLERS USED WERE REPORTED TO HAVE BROKEN JOYSTICKS. AFTER THE 2ND CONTROLLER (SERIAL NUMBER (B)(6)) BROKE, THE SCOPE STARTED TO DRIFT SIGNIFICANTLY INTO THE RIGHT UPPER LOBE, AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO CLINICAL SYMPTOMS WERE REPORTED DURING THE CASE, AND NO TREATMENT OR INTERVENTION WAS REQUIRED. REVIEW OF THE PROCEDURE VIDEO DURING RETURN PRODUCT INVESTIGATION ON (B)(6)2024 REVEALED THAT SCOPE STARTED MOVING WITHOUT USER INPUT, FOLLOWED BY THE SCOPE TIP PUNCTURING THE AIRWAY TISSUE INTO THE PARENCHYMA (LUNG TISSUE). A "SCOPE BUCKLING" MESSAGE ALSO APPEARED. UNCONTROLLED SCOPE MOVEMENT CONTINUED FOR 23 SECONDS. FINDINGS FROM THE INVESTIGATION ATTRIBUTES THE SCOPE DRIFT TO THE JOYSTICK ASSEMBLY PULLING OUT OF THE POTENTIOMETER. THE POTENTIOMETER CAME TO REST AT A STEADY OUTPUT VALUE THAT COMMANDED UNINTENDED MOTION WITHOUT USER INPUT. ALTHOUGH NO INJURY TO THE PATIENT WAS FOUND DURING THE CASE THE INVESTIGATION OF THE CASE IDENTIFIED A NON-SERIOUS INJURY. IF THE MALFUNCTION IDENTIFIED OF THE GALAXY SYSTEM IN THIS CASE AND IF IT WERE TO RECUR, IT COULD LEAD TO INJURY, IT IS REPORTABLE. THE INITIAL SUBMISSION WAS MADE (B)(6)2024, ADDITIONAL ATTEMPT MADE (B)(6)2024. SUPPORT FROM EMDR HELPDESK RECEIVED A RESUBMISSION REQUESTED.
ON (B)(6) 2024, THE PATIENT WAS UNDERGOING A BIOPSY PROCEDURE FOR A 9MM LESION IN THE RIGHT LOWER LOBE. DURING THE PROCEDURE, BOTH WIRED CONTROLLERS USED WERE REPORTED TO HAVE BROKEN JOYSTICKS. AFTER THE 2ND CONTROLLER (SERIAL NUMBER (B)(6)) BROKE, THE SCOPE STARTED TO DRIFT SIGNIFICANTLY INTO THE RIGHT UPPER LOBE, AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO CLINICAL SYMPTOMS WERE REPORTED, AND NO TREATMENT OR INTERVENTION WAS REQUIRED. REVIEW OF THE PROCEDURE VIDEO DURING RETURN PRODUCT INVESTIGATION ON 03JUL2024 REVEALED THAT SCOPE STARTED MOVING WITHOUT USER INPUT, FOLLOWED BY THE SCOPE TIP PUNCTURING THE AIRWAY TISSUE INTO THE PARENCHYMA (LUNG TISSUE). A "SCOPE BUCKLING" MESSAGE ALSO APPEARED. UNCONTROLLED SCOPE MOVEMENT CONTINUED FOR 23 SECONDS. FINDINGS FROM THE INVESTIGATION ATTRIBUTES THE SCOPE DRIFT TO THE JOYSTICK ASSEMBLY PULLING OUT OF THE POTENTIOMETER. THE POTENTIOMETER CAME TO REST AT A STEADY OUTPUT VALUE THAT COMMANDED UNINTENDED MOTION WITHOUT USER INPUT. ALTHOUGH NO INJURY TO THE PATIENT WAS FOUND DURING INVESTIGATION OF THE CASE, THE INVOLVEMENT OF THE GALAXY SYSTEM IN THIS CASE AND IF IT WERE TO RECUR, COULD LEAD TO PNEUMOTHORAX AND/OR BLEEDING, IT IS REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2070835 | GALAXY SYSTEM | GALAXY SYSTEM | EOQ | NOAH MEDICAL CORP. | 2024040806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Unknown | Other |