Always-On Tip Tracked Forceps, 1.8mm OD, Serrated Cup INS-0372Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815686020576), received between Aug 10, 2018 and Dec 13, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 other recalls cover devices cleared under the same FDA submission (K122106); they may or may not involve this specific model.

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-2664-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 15, 2023Class IIOpen, Classified

   Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

   Z-2264-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY CONTACTED VERAN TECHNICAL SUPPORT (VSUPPORT) FOR ROUTINE CASE SUPPORT FOR A NAVIGATED BRONCHOSCOPY PROCEDURE. THEY REPORTEDLY REGISTERED WITH FORCEPS (ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP). THE PHYSICIAN STARTED TO SAMPLE WITH THE FORCEPS. AFTER THE SECOND SAMPLE, HE HAD TO FLUSH WITH COLD SALINE BECAUSE THERE WAS BLEEDING. THE PHYSICIAN INDICATED THAT THERE WAS NOT AN EXCESSIVE AMOUNT OF BLEEDING AND HE WAS ABLE TO CONTROL THE BLEEDING WITH COLD SALINE. THE PHYSICIAN SAID THAT HE WAS NOT GOING TO HAVE TO PERFORM ANY ADDITIONAL INTERVENTIONS. THE NAVIGATED PROCEDURE WAS ABORTED BECAUSE THE PHYSICIAN DID NOT WANT TO TAKE ANY MORE SAMPLES IN FEAR OF POTENTIALLY CAUSING EXCESSIVE BLEEDING. THERE WAS NO ALLEGATION OF A MALFUNCTION OF ANY VERAN DEVICES. THIS REPORT IS BEING SUBMITTED DUE TO THE ABORTED PROCEDURE AND BLEEDING THAT REQUIRED MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18320656 ↗
• MalfunctionJun 29, 2023Defective Component; Defective Component

  THE FACILITY REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL END OF THE FORCEPS (INS-0372 ALWAYS-ON TIP TRACKED FORCEPS, 1.8MM OD, SERRATED CUP) APPEARED "VERY ROUGH" ON THE ENDOSCOPIC IMAGE. THE CUSTOMER WAS CONCERNED THAT THIS WOULD CAUSE SCOPE DAMAGE, ESPECIALLY WHEN FLEXED. HOWEVER, THIS HAD NO EFFECT ON THE ABILITY TO OPEN, CLOSE OR USE THE FORCEPS. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE AFTER SWITCHING TO A NEW INSTRUMENT. THERE WAS NO PROCEDURAL DELAY AND THERE WAS NO INJURY TO THE PATIENT OR USER AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226392 ↗
• MalfunctionJun 16, 2023Defective Component; Defective Component

  AFTER THE INTENDED PROCEDURE WAS COMPLETED, THE PHYSICIAN NOTICED THE INS-0372 (ALWAYS-ON TIP TRACKED SERRATED FORCEPS) SHEATH HAD RIDGES ON IT. THE DOCTOR SAID THE RIDGES CAUSED DAMAGE TO THE WORKING CHANNEL OF THEIR SCOPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE INS-0372 (SUBJECT DEVICE) AND INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) TO OBTAIN TISSUE SAMPLES. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THIS ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17147605 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT DEVELOPED A PNEUMOTHORAX, WHICH REQUIRED A CHEST TUBE AND ADMITTANCE TO THE HOSPITAL AFTER A PROCEDURE WITH THE VERAN SPIN SYSTEM AND ENDOBRONCHIAL INSTRUMENTS.

  Patient problems: Pneumothorax

  MAUDE report 15634946 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  VERAN VSUPPORT WAS MADE AWARE ON 01-OCT-2021 OF A RESEARCH ARTICLE PUBLISHED IN "LUNG." THE TITLE OF THE RESEARCH ARTICLE IS: 4D ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR THE SAMPLE OF PULMONARY LESIONS: FIRST EUROPEAN REAL-LIFE EXPERIENCE. THE ARTICLE MENTIONS USING THE VERAN SPIN THORACIC NAVIGATION SYSTEM AND TWO OF THE VERN INSTRUMENTS: FORCEPS AND 21 GA NEEDLE. THE ARTICLE STATES THAT THERE WAS ONE INCIDENCE OF PNEUMOTHORAX WHILE USING THE VERAN SPIN NAVIGATION SYSTEM. NO ADDITIONAL INFORMATION WAS GIVEN IN THE ARTICLE.

  Patient problems: Pneumothorax

  MAUDE report 14190220 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS AN 88F WITH NO PRE-EXISTING CONDITIONS. METASTATIC LUNG CANCER WAS ORIGINALLY SUSPECTED PRIOR TO THE CASE. AFTER THE 5TH BITE WITH THE SERRATED FORCEPS, THE PATIENT BEGAN BLEEDING EXCESSIVELY, WITH BLOOD EVENTUALLY COMING UP THE ET TUBE. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING BY APPLYING PRESSURE WITH THE SCOPE AND THE PATIENT WAS BEGINNING TO STOP ON HER OWN. PT WAS EXTUBATED THE NEXT DAY. NO PNEUMOTHORAX WAS NOTED. PT. STAYED IN THE HOSPITAL 4 DAYS AND WAS SET TO BE DISCHARGED ON DAY 5. PHYSICIAN STATED THAT AGE AND PRESCRIPTION OF ELIQUIS PLAYED A ROLE IN EXCESSIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11148822 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, PATIENT WAS UNDER SEDATION FOR A BIOPSY OF A SUSPECT NODULE MEASURING 38 MM IN THE LUNG UTILIZING THE IG4 SYSTEM AND ASSOCIATED INSTRUMENTATION. DR. (B)(6) STARTED WITH THE 19GA ALWAYS- ON TIP TRACKED (AOTT) BIOPSY NEEDLE AND GOT TO THE TARGET WITH EASE. AFTER TWO PASSES, PATHOLOGY SAW ATYPICAL CELLS LOOKING LIKE NON SMALL CELL BUT WANTED MORE SAMPLES. COMPLETED SIX MORE PASSES WITH THE NEEDLE AND THEN SWITCHED TO THE ALWAYS-ON TIP TRACKED SERRATED FORCEPS. RECEIVED ONE GOOD SAMPLE AND THE PATIENT STARTED TO BLEED. THE PHYSICIAN WASHED THE AREA WITH EPI, KEPT THE SCOPE IN AN ADDITIONAL 5 MINUTES TO WATCH THE BLEEDING. THE BLEEDING SLOWED DOWN AND THE PATIENT WAS ABLE TO GO HOME SAME DAY.

  Patient problems: Blood Loss

  MAUDE report 7772916 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122106. One submission often covers many models, so check the product and lot details in each record.

• Z-2663-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "
• Z-2662-2023 · Aug 10, 2023 · Open, Classified
  Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016
• Z-2659-2023 · Aug 10, 2023 · Open, Classified
  Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50H
• Z-2661-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN
• Z-2269-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomogr
• Z-2267-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where comp
• Z-2265-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures whe
• Z-2262-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomograph
• Z-2268-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where co
• Z-2266-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures wher
• Z-2263-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomo