SPiNPerc Biopsy Needle Guide Kit INS-5600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815686020736), received between Jun 17, 2021 and Apr 7, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 10, 2023Class IIOpen, Classified

   Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

   Z-2661-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT VERAN ENDOBRONCHIAL FORCEPS WERE USED TO REGISTER THE PATIENT ANATOMY WITH THE SPIN SYSTEM BEFORE THE PROCEDURE. A SPIN THORACIC NAVIGATION SYSTEM AND AN INS-5029 (19UTW 105MM ALWAYS-ON TIP TRACKED BIOPSY NEEDLE, CHIBA POINT- SUBJECT DEVICE) WERE USED FOR A PERCUTANEOUS BIOPSY PROCEDURE. TISSUE SAMPLES WERE SUCCESSFULLY TAKEN. THE PROCEDURE WAS COMPLETED. AFTER THE COMPLETION OF THE PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. USER FACILITY REPORTED THAT THE PATIENT "SELF-HEALED" AND WAS DISCHARGED. THIS REPORT IS BEING SUBMITTED FOR THE SPIN PERC BIOPSY NEEDLE KIT (INS-5600) WHICH CONTAINS THE INS-5029 19UTW 105MM ALWAYS-ON TIP TRACKED BIOPSY NEEDLE, CHIBA POINT. A SEPARATE MEDWATCH REPORT FOR THE FORCEPS THAT WERE USED DURING THE REGISTRATION FOR THE PROCEDURE IS BEING SUBMITTED TO THE FDA ON MEDWATCH 3007222345-2023-00018.

  Patient problems: Pneumothorax

  MAUDE report 16704587 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE PERFORMED ON A FEMALE AND SAMPLES TAKEN. NO PNEUMOTHORAX UPON XRAY IMMEDIATELY AFTER PROCEDURE, BUT A SMALL ONE APPEARED WHILE IN RECOVERY. PATIENT ADMITTED AND DISCHARGED TWO DAYS LATER. ADMISSION WAS ALSO DUE TO STAYING IN0HOSE FOR ONCOLOGY. PNEUMOTHORAX RESOLVED QUICKLY.

  Patient problems: Pneumothorax

  MAUDE report 15229273 ↗
• InjuryFeb 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ENDOBRONCHIAL BIOPSY PROCEDURE WAS PERFORMED WITH FORCEPS BEFORE MOVING ONTO THE PERCUTANEOUS PROCEDURE. DURING THE SECOND REGISTRATION, BOTH THE MIN AND SECONDARY CARINAS WERE ACCURATE. DURING THE POST OP CT SCAN, IT WAS FOUND THAT THE PATIENT HAD A PARTIAL PNEUMOTHORAX. NO CHEST TUBE WAS PLACED. THE PATIENT WENT HOME ON THE SAME DAY. THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY AND AN XRAY CONFIRMED THAT THE PNEUMOTHORAX HAD RESOLVED ON ITS OWN.

  Patient problems: Pneumothorax

  MAUDE report 13518953 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem

  PATIENT DID HAVE A LOBECTOMY ON THE LEFT LOWER LOBE. PATIENT WAS IN RIGHT LATERAL DECUBITUS POSITION. DOCTOR HAD DIFFICULTY REGISTERING, BUT WAS ABLE TO MOVE ON. DOCTOR DID ATTEMPT A PERCUTANEOUS APPROACH, BUT WAS COMPLAINT OF POOR SAMPLES. AFTER THE PROCEDURE, THE PATIENT RECEIVED A CHEST X-RAY AND IT WAS NOTED TO HAVE A PNEMOTHROAX. DR. PLACES A CHEST TUBE AND THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Pneumothorax

  MAUDE report 13419092 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AN ENDOBRONCHIAL BIOPSY PROCEDURE WAS PERFORMED WITH FORCEPS BEFORE MOVING ONTO THE PERCUTANEOUS PROCEDURE. DURING THE SECOND REGISTRATION, BOTH THE MIN AND SECONDARY CARINAS WERE ACCURATE. DURING THE POST OP CT SCAN, IT WAS FOUND THAT THE PATIENT HAD A PARTIAL PNEUMOTHORAX. NO CHEST TUBE WAS PLACED. THE PATIENT WENT HOME ON THE SAME DAY. THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY AND AN XRAY CONFIRMED THAT THE PNEUMOTHORAX HAD RESOLVED ON ITS OWN.

  Patient problems: Pneumothorax

  MAUDE report 12351719 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DATE OF PROCEDURE: (B)(6) 2021. DATE OR REPORT: 18-MAY-2021. PHYSICIAN ATTEMPTED A NAVIGATIONAL BRONCHOSCOPY BUT WAS UNSUCCESSFUL IN REACHING THE TARGET. THE PATIENT WAS TRANSITIONED INTO A LEFT LATERAL DECUBITUS POSITION AND PROCEEDED WITH REGISTRATION, HOWEVER BOTH THE MAIN AND LEFT SECONDARY CARINA WERE LINING UP. A LUMEN REFINEMENT WAS CONDUCTED. ONCE BOTH THE MAIN AND LEFT SECONDARY CARINA WERE CHECK AND BOTH WERE ALIGNED CORRECTLY, THE PERC PROCEDURE BEGAN. THE PHYSICIAN OBTAINED THE FIRST BIOPSY USING THE BIOPSY GUN WITH A 2CM THROW. (B)(6) WAS PRESENT IN THE ROOM AND CONFIRMED THAT THE FIRST SAMPLE TAKEN WAS BENIGN. DR. (B)(6) WENT BACK AND CONTINUED TO TAKE BIOPSIES WITH BOTH THE BIOPSY GUN AND FNA NEEDLE, BUT WAS UNSUCCESSFUL OBTAINING ANY TISSUE. AFTER 4 FAILED ATTEMPTS, THE VERAN MEDICAL REPRESENTATIVE IN THE ROOM CALLED INTO VSUPPORT. VSUPPORT CHECKED THE REGISTRATION, ALONG WITH THE ENTRY POINT AND TRAJECTORY OF PERC NEEDLE. THE NEEDLE WAS NEVER REMOVED FROM THE PATIENT. VSUPPORT CONFIRMED THE NEEDLE WAS IN THE NODULE. AS THE PHYSICIAN COMPLETED THE PROCEDURE, AN ULTRASOUND TECHNICIAN WAS CALLED INTO THE ROOM TO CHECK FOR PNEUMOTHORAX AND IT APPEARED NEGATIVE. A CHEST

  Patient problems: Pneumothorax; Respiratory Arrest; Tachycardia

  MAUDE report 12022252 ↗