VIDEO SYSTEM OTV-SC (UDI 04953170136894)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04953170136894), received between Jan 4, 2021 and Mar 23, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2025Break; Poor Quality Image; Connection Problem; Break; Poor Quality Image; Connection Problem

  NO ADDITIONAL INFORMATION RECEIVED FORM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21674596 ↗
• MalfunctionMar 13, 2025No Display/Image; No Display/Image

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595435 ↗
• MalfunctionJan 9, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEO SYSTEM CENTER MONITOR WAS SHOWING BLUE WITH MULTIPLE LINES GOING DOWN. THE ISSUE WAS FOUND DURING PREPARATION FOR USE IN A THERAPEUTIC CYSTOSCOPY WITH INTRA-DETRUSOR BOTOX INJECTIONS PROCEDURE. THE PATIENT WAS NOT UNDER SEDATION. THE PROCEDURE WAS SLIGHTLY DELAYED, AND WAS COMPLETED WITH A SIMILAR NON-OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474998 ↗
• MalfunctionNov 29, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS NO IMAGE FROM THE VIDEO PROCESSOR. THE ISSUE OCCURRED DURING REINSTALLATION AFTER THE UNIT HAD BEEN RELOCATED. THERE WAS NO PATIENT OR USER HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230237 ↗
• MalfunctionOct 13, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VIDEO SYSTEM HAD AN IMAGE PROBLEM. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE (URETERAL LITHOTRIPSY). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936465 ↗
• MalfunctionSep 17, 2023No Display/Image; No Display/Image

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE VIDEO SYSTEM HAD NO IMAGE FROM ANY OUTPUT PORTS DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762308 ↗
• MalfunctionAug 24, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR USE IN A DIAGNOSTIC PROCEDURE, THE IMAGE DID NOT APPEAR ON THE VIDEO SYSTEM. THE INSPECTION WAS STOPPED, AND TROUBLESHOOTING WAS CONDUCTED; HOWEVER, THE CAUSE WAS UNKNOWN. THE INTENDED PROCEDURE COULD NOT BE COMPLETED, AND SUBSEQUENT INSPECTIONS WERE ABORTED. WHILE THE PROCEDURE WAS CANCELLED, THERE IS NO EVIDENCE OF ANY EMERGENT CONDITIONS THAT AROSE THAT WOULD POSE THE PATIENT AT RISK FOR ADVERSE EVENTS OR ANY PRE-EXISTING MEDICAL CONDITIONS THAT WOULD ADVERSELY IMPACT THE PATIENT. THERE IS NO EVIDENCE OF ANY MISSED CRITICAL DIAGNOSIS OR TREATMENT DUE TO THE CANCELLED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620040 ↗
• MalfunctionJul 13, 2023No Display/Image; Communication or Transmission Problem; Output Problem; No Display/Image; Communication or Transmission Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE OTV-SC VIDEO SYSTEM WAS NOT SENDING VIDEO SIGNAL TO THE MONITOR, NO IMAGE. THE ISSUE WAS NOT FOUND DURING A CLINICAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321326 ↗
• MalfunctionJun 16, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE OTV-SC VIDEO SYSTEM HAD NO IMAGE. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144628 ↗
• MalfunctionDec 29, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE VIDEO SYSTEM FAILED TO PRODUCE AN IMAGE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069849 ↗
• MalfunctionDec 13, 2022No Display/Image; No Display/Image

  OLYMPUS WAS INFORMED BY THE CLINICAL TECHNICIAN AT THE USER FACILITY THAT THE CUSTOMER VIDEO PROCESSOR HAS A ¿DISTORTED IMAGE, NO IMAGE¿. THE CUSTOMER REPORTED ISSUE WAS FOUND DURING THE INSPECTION BEFORE USE. NO DEATH, INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971840 ↗
• MalfunctionOct 7, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THERE WAS NO IMAGE DISPLAYED WHEN THE CAMERA HEAD AND THE VIDEO SYSTEM WAS CONNECTED (WHILE USING THE VIDEO OUT/COAX PORT). ONLY GRAY, HORIZONTAL BARS WERE DISPLAYED. NO ERROR CODES WERE DISPLAYED. ANOTHER DISPLAY WAS USED; HOWEVER, THE ISSUE PERSISTED. THE REPORTED ISSUE OCCURRED WHILE PREPARING THE SUBJECT DEVICE, PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. IT WAS SUSPECTED THAT THERE WAS AN ISSUE WITH EITHER THE VIDEO SYSTEM OR THE CAMERA HEAD. THIS REPORT IS BEING SUBMITTED FOR THE NO IMAGE ISSUE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED ISSUE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED FOR THE VIDEO SYSTEM (OTV-SC) UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE CAMERA HEAD (MAJ-554) IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566879 ↗
• MalfunctionJul 12, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  OLYMPUS WAS INFORMED BY THE CUSTOMER THAT THE VIDEO SYSTEM HAS AN ¿IMAGE PROBLEM¿. THE CUSTOMER¿S REPORTED PROBLEM WAS FOUND DURING AN UNSPECIFIED EVENT. NO DEATH, INJURY OR HARM, WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14994078 ↗
• MalfunctionJan 18, 2021No Display/Image; No Display/Image

  DURING THE PREPARATION FOR USE, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11190932 ↗
• MalfunctionJan 4, 2021No Display/Image; No Display/Image

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AN ENDOSCOPIC IMAGE WAS NOT DISPLAYED ON THE MONITOR. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11114712 ↗