TIPCAM1 26605BARecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 04048551347843), received between Oct 4, 2021 and Aug 27, 2026 — classified as 5 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (12 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Optical Distortion

  The following was reported: "On (b)(6) 2026, medical staff of the anesthesiology department encountered the issue of screen bar flickering on the lens while using the 3D high definition electronic laparoscope, which prevented the medical staff from accurately assessing the patient's condition." No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482791 ↗
• MalfunctionJul 28, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060729 ↗
• MalfunctionJul 6, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT "3D CAMERA HEAD FLICKERING.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25720971 ↗
• MalfunctionJun 22, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: "FOGGY."

  Patient problems: Insufficient Information

  MAUDE report 25587390 ↗
• MalfunctionJun 11, 2026Optical Problem

  THE FOLLOWING WAS REPORTED: "INTRA-OPERATIVELY, STORZ ENDOSCOPE EXPERIENCED SEVERAL ENDOSCOPE IMAGE FROZEN ISSUES. THE ISSUES WERE RESOLVED AFTER UNPLUGGING THE ENDOSCOPE CABLE AND PLUGGING IT BACK IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479980 ↗
• MalfunctionMay 20, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT "DURING A ROBOTIC LAPAROSCOPIC REPAIR OF A SUPRAPUBIC HERNIA PRIOR TO SCOPE INSERTION, THE ENDOSCOPE SHOWED AN INTERMITTENTLY FLASHING IMAGE ON THE OPERATING ROOM TEAM INTERFACE AND THE SPARE MONITOR, BUT NOT ON THE SURGEON CONSOLE. THE DATA CABLE OF THE TOWER WAS DISCONNECTED AND RECONNECTED AND THE EXTENSION CORD WAS ALSO EXCHANGED, BUT NEITHER ACTION RESOLVED THE ISSUE. THE ONLY THING THAT WORKED WAS REPLACING THE SCOPE, AFTER WHICH THE SYSTEM FUNCTIONED PROPERLY. THERE WAS NO PATIENT INJURY.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236000 ↗
• MalfunctionMay 12, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: "THE SCREEN FLASHES AFTER WORKING FOR A WHILE."

  Patient problems: Insufficient Information

  MAUDE report 25151355 ↗
• InjuryApr 21, 2026Break

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HARTMANN'S REVERSAL PROCEDURE, AT THE TIME OF SPLENIC FLEXURE MOBILIZATION, AN IMAGE QUALITY ISSUE SUDDENLY OCCURRED ON THE ENDOSCOPE WHILE THE SURGEON WAS OPERATING. THE IMAGE CHANGED, PROMPTING THE WITHDRAWAL, CLEANING, AND REINSERTION OF THE ENDOSCOPE WAS DONE BUT THE ISSUE PERSISTED. THE STORZ SYSTEM WAS THEN REBOOTED BY TURNING OFF BOTH THE BOTTOM AND TOP UNITS AND TURNED THEM BACK ON, BUT THE ISSUE REMAINED UNRESOLVED. FINALLY, A NEW ENDOSCOPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NEW INFORMATION RECEIVED: THERE WAS A PROLONGATION OF PROCEDURE OF 90 MINUTES. DUE TO THAT, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945595 ↗
• MalfunctionApr 20, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: BLURRED IMAGE/ COLOR CAST. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24932068 ↗
• MalfunctionApr 20, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: CCD & CMOS / FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24932059 ↗
• MalfunctionApr 11, 2026Optical Distortion

  THE FOLLOWING WAS REPORTED: 3D ELECTRONIC ENDOSCOPE FLICKERING AND CABLE BASE FRACTURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850209 ↗
• MalfunctionApr 8, 2026Poor Quality Image

  IT WAS REPORTED THAT THE IMAGE FROM THE ENDOSCOPE CAMERA WAS FLASHING, AND WITH CERTAIN CONNECTIONS, THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT UNKNOWN EQUIPMENT HAD BEEN CONNECTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818896 ↗
• MalfunctionMar 9, 2026Output Problem

  THE FOLLOWING WAS REPORTED: IT WAS REPORTED THAT, DURING USE, THE ENDOSCOPE HAD FAULTY OPTICS AND A DAMAGED CABLE. IT IS BEING EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552791 ↗
• MalfunctionFeb 17, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24369342 ↗
• MalfunctionFeb 9, 2026Erratic or Intermittent Display; Insufficient Device Problem Information

  IT WAS REPORTED THAT IMAGE WAS FLICKERING, COLOR DISTORTION, AND GARBLED SCREEN; CANNOT BE USED NORMALLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299940 ↗
• MalfunctionFeb 6, 2026Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING THE PARAESOPHAGEAL HERNIA ROBOTIC LAPAROSCOPIC PROCEDURE, THE ENDOSCOPE WAS DIFFICULT TO MANIPULATE LAPAROSCOPICALLY. WHEN PLACING THE 11MM PORT WITH THE OPTICAL OBTURATOR, THE SURGEON COULD NOT SEE THE TISSUES WELL. THERE WAS NO IMPACT TO THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278561 ↗
• MalfunctionJan 29, 2026Erratic or Intermittent Display; No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMAGE ON THE SCOPE BEGAN FLICKERING DURING PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211141 ↗
• MalfunctionJan 29, 2026Poor Quality Image; Scratched Material

  IT WAS REPORTED: "SHADOW AND BLURRED IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211012 ↗
• MalfunctionJan 15, 2026Erratic or Intermittent Display; Insufficient Device Problem Information

  IT WAS REPORTED THAT "DURING A ROBOTIC LAPAROSCOPIC SURGERY, THE ENDOSCOPE DELIVERED A FLICKERING IMAGE. THERE WAS NO PATIENT INJURY." IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY OR PROLONGATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089606 ↗
• MalfunctionDec 10, 2025Poor Quality Image; Device Damaged Prior to Use; Defective Device; Poor Quality Image; Device Damaged Prior to Use; Defective Device

  IT WAS REPORTED THAT THE 3D IMAGE IS TOO DARK AND THAT THE PICTURE CANNOT BE PROVIDED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770494 ↗
• MalfunctionNov 19, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE WAS FLICKERING & FROZEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598259 ↗
• MalfunctionSep 3, 2025No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TIPCAM HAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956707 ↗
• MalfunctionAug 22, 2025Erratic or Intermittent Display; Device Handling Problem; Erratic or Intermittent Display; Device Handling Problem

  ACCORDING TO THE INFORMATION RECEIVED, DURING A ROBOTIC LAPAROSCOPIC RADICAL NEPHRECTOMY AT THE END OF THE PROCEDURE, THE ENDOSCOPE'S IMAGE WAS NOT VISIBLE AS IT APPEARED STRIPED AND INTERMITTENT. THEN, AN ERROR APPEARED READING "WARNING: ENDOSCOPE NOT SUPPORTED. ENDOSCOPE FUNCTIONS MAY NOT OPERATE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877643 ↗
• MalfunctionJun 9, 2025Corroded; Erratic or Intermittent Display; Output Problem; Scratched Material; Corroded; Erratic or Intermittent Display; Output Problem; Scratched Material

  IT WAS REPORTED THAT SPORADIC IMAGE DISAPPEARS AFTER MOVEMENT / LIGHT DIMS. CAMERA DOES NOT CONNECT TO LSK TOWER. MESSAGE: HEAD IS INCOMPATIBLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167187 ↗
• MalfunctionMay 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PRE-OPERATIVELY, AS SOON AS THE ENDOSCOPE WAS CONNECTED, THERE WAS A RED WARNING ALARM: "THE ENDOSCOPE IMAGE IS FROZEN". THE ENDOSCOPE WAS CHANGED BUT STILL RECEIVED THE SAME ERROR. THE STORZ WAS REBOOTED BUT STILL THE SAME ERROR. THE SURGEON DECIDED TO CONVERT TO ANOTHER ROBOTIC SYSTEM. THERE WAS NO HARM TO THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFRENCE MDR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039482 ↗