NA 26606BCARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04048551425688), received between Jun 24, 2022 and Sep 18, 2026 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830695 ↗
• MalfunctionMar 16, 2026Optical Problem

  IT WAS REPORTED THAT THERE WAS NO IMAGE, AFTER A WHILE "NON COMPATIBLE HEAD" COMES UP ON SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613780 ↗
• MalfunctionMar 16, 2026Output Problem

  THE FOLLOWING WAS REPORTED: "AFTER POWER-ON, THE MAIN UNIT FAILED TO RECOGNIZE THE CAMERA. THE SURGERY WAS COMPLETED AFTER REPLACING THE EQUIPMENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612811 ↗
• MalfunctionMar 14, 2026Output Problem

  THE FOLLOWING WAS REPORTED: "AFTER POWER-ON, THE MAIN UNIT FAILED TO RECOGNIZE THE CAMERA. THE SURGERY WAS COMPLETED AFTER REPLACING THE EQUIPMENT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599929 ↗
• MalfunctionMar 11, 2026Material Protrusion/Extrusion; Optical Distortion

  THE FOLLOWING WAS REPORTED: "THE DISPLAY BECAME DISTORTED AFTER PROLONGED USE DURING THE PREOPERATIVE CHECK." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571621 ↗
• MalfunctionMar 11, 2026Display or Visual Feedback Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24571547 ↗
• MalfunctionFeb 26, 2026Defective Component; Optical Distortion

  THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION ABOUT THE DEFECT OR MALFUNCTION. ACCORDING TO THE INVESTIGATION RESULTS: THE IMAGE IS BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24464278 ↗
• MalfunctionFeb 17, 2026Circuit Failure; Output Problem; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: "ON (B)(6) 2025, THE HOSPITAL REPORTED A MALFUNCTION. THE INITIAL FAULT SYMPTOM WAS YELLOWISH IMAGES. ON-SITE INSPECTION OBSERVED YELLOW DEPOSITS AT THE LIGHT GUIDE INTERFACE OF THE SCOPE. AFTER CLEANING WITH THE COMPANY'S SPECIAL FROSTED LENS CLEANING PASTE, THE FAULT SUDDENLY CHANGED TO THE SCOPE SHOWING "UNABLE TO RECOGNIZE THE MAIN UNIT" WITH NO IMAGE. THE SYMPTOM PERSISTED AFTER MULTIPLE TESTS. RETURNED TO RC FOR DETECTION AND CONFIRMED AS A SCOPE MALFUNCTION." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373393 ↗
• InjuryFeb 17, 2026Break; Material Discolored; No Display/Image; Device Damaged Prior to Use

  IT WAS REPORTED THAT "THE DEVICE WAS INSTALLED AND PUT INTO USE IN (B)(6) 2025. ON (B)(6) 2026, DURING A SURGICAL PROCEDURE, NO IMAGE WAS DISPLAYED AFTER THE SCOPE WAS CONNECTED TO THE MAIN UNIT. INSPECTION REVEALED A CRACK AT THE ROOT OF THE CONNECTING CABLE. VERIFIED WITH CSSD: NO CRACKS WERE FOUND PRIOR TO STERILIZATION." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED BY 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369113 ↗
• InjuryFeb 17, 2026No Display/Image

  IT WAS REPORTED THAT "THE DEVICE WAS INSTALLED AND PUT INTO USE IN (B)(6) 2025. ON (B)(6) 2026, DURING A SURGICAL PROCEDURE, NO IMAGE WAS DISPLAYED AFTER THE SCOPE WAS CONNECTED TO THE MAIN UNIT. INSPECTION REVEALED A CRACK AT THE ROOT OF THE CONNECTING CABLE. VERIFIED WITH CSSD: NO CRACKS WERE FOUND PRIOR TO STERILIZATION." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED BY 35 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369111 ↗
• InjuryFeb 10, 2026Poor Quality Image; Defective Component

  IT WAS REPORTED THAT IMAGE IS BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302481 ↗
• MalfunctionFeb 3, 2026Device Damaged Prior to Use; Defective Component; Output Problem

  THE FOLLOWING WAS REPORTED: "THE PATIENT WAS ALREADY ON THE OPERATING TABLE. DURING INSTALLATION ON THE TABLE PRIOR TO SURGERY, A PROMPT "INCOMPATIBLE CAMERA" APPEARED, AND THERE WAS NO IMAGE ON THE SCREEN. NORMAL FUNCTION WAS RESTORED AFTER REPLACING THE SCOPE. NO SIGNIFICANT SURGICAL DELAY WAS CAUSED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254743 ↗
• MalfunctionFeb 3, 2026Material Discolored; Material Fragmentation; Output Problem

  THE FOLLOWING WAS REPORTED: THE PATIENT WAS ALREADY ON THE OPERATING TABLE. DURING INSTALLATION ON THE TABLE PRIOR TO SURGERY, A PROMPT INCOMPATIBLE CAMERA APPEARED, AND THERE WAS NO IMAGE ON THE SCREEN. NORMAL FUNCTION WAS RESTORED AFTER REPLACING THE SCOPE. NO SIGNIFICANT SURGICAL DELAY WAS CAUSED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248731 ↗
• InjuryFeb 2, 2026Poor Quality Image

  IT WAS REPORTED THAT IMAGE IS BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE RISK IS COVERED IN THE RELATED RISK FILE (SAP-ID: (B)(4), VERSION: BF; RISK ID: (B)(4); SEVERITY-LEVEL: 3 (TISSUE TRAUMA, REVERSIBLE, ASSOCIATED WITH SIGNIFICANT PROLONGATION OF THE PROCEDURE / DURATION OF ANESTHESIA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231047 ↗
• MalfunctionJan 20, 2026Poor Quality Image

  IT WAS REPORTED THAT THE TIPCAM GETTING SHADOWS INSTEAD OF A CRYSTAL CLEAR 3-D IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127022 ↗
• MalfunctionJun 16, 2025Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT "THE UNIT GETS HOTTER THAN THE 35 C INDICATED ON THE IFU". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. IT WAS INITIALLY REPORTED THAT "THE UNIT GETS HOTTER THAN THE 35 C INDICATED ON THE IFU". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ACCORDING TO FURTHER INFORMATION THE CUSTOMER CLAIMS THAT THE EQUIPMENT IS GETTING WARMER AND WARMER. THIS CAUSES HIM DISCOMFORT TO WORK. IT WAS INDICATED THAT THE UNIT REACHED A TEMPERATURE OF 38°C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212199 ↗
• InjuryJul 19, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A LAP HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024, THE SURGICAL TECHNICIAN (CST) WAS HOLDING THE TIPCAM WHERE THE LIGHT CORD PLUGS INTO THE PROXIMAL END OF THE SCOPE. THE CST BURNED HER FINGER ON THE JUNCTION WHERE THE LIGHT CORD ATTACHES TO THE LIGHT SOURCE. THIS CAUSED A SLIGHT SKIN DISCOLORATION ON HER FINGER, AND NO TREATMENT WAS DEEMED NECESSARY THEN. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER INCIDENTS. ACCORDING TO THE CUSTOMER, THE CST IS DOING FINE NOW.

  Patient problems: Burn(s)

  MAUDE report 19785970 ↗
• InjuryFeb 15, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED TO KST THAT AFTER (ALMOST) 2 HOURS OF USE, THE HANDLE GETS VERY HOT AND A DOCTOR DEVELOPED A RED SPOT OF BURNED TISSUE AFTER USE.

  Patient problems: Burn(s)

  MAUDE report 16380585 ↗
• InjuryFeb 15, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED TO KST THAT AFTER (ALMOST) 2 HOURS OF USE, THE HANDLE GETS VERY HOT AND A DOCTOR DEVELOPED A RED SPOT OF BURNED TISSUE AFTER USE.

  Patient problems: Burn(s)

  MAUDE report 16380568 ↗
• InjuryJun 24, 2022Use of Device Problem; Temperature Problem; Use of Device Problem; Temperature Problem

  AS PER MANUFACTURER INCIDENT REPORT # (B)(4) WE RECEIVED FROM THE FACTORY IN (B)(6): WHILE PREPARING FOR LAPAROSCOPIC SURGERY, 26606BCA THAT WAS CONNECTED TO THE LIGHT SOURCE DEVICE(TL400) WAS PLACED ON THE PATIENT'S BODY. A BURN (10MM IN DIAMETER) OCCURRED ON THE PATIENT'S CHIN DUE TO THE LIGHT EMISSION FROM THE DISTAL TIP OF THE TELESCOPE.

  Patient problems: Burn(s)

  MAUDE report 14799204 ↗