NA 242300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705026180), received between Nov 19, 2018 and Jan 4, 2024 — classified as 3 injuries, 9 malfunctions.

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

• MalfunctionJan 4, 2024Computer Software Problem; Output Problem; Computer Software Problem; Output Problem

  IT WAS REPORTED BY AN AFFILIATE THAT PRIOR TO A SURGICAL PROCEDURE ON AN UNKNOWN DATE THE CAMERA CONTROL UNIT DEVICE HAD INTERMITTENT ISSUES DUE TO A SOFTER GLITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443262 ↗
• MalfunctionOct 16, 2020Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: WE HAVE AN ISSUE WITH OUR OLIVE OVB1 CAMERA CONTROL UNIT (SN:(B(4) AND CAMERA (SN: (B)(4). THE CAMERA CONTROL UNIT GETS OFF FOR SOME TIME DURING URS CASE. THE SAME OCCURRED AFTER RESTARTING THE UNIT AGAIN. THERE WAS NO CLEAR IMAGE FORMED AND STRUGGLED A LOT IN BETWEEN. THE UNIT ALSO SHOWS 'INVALID CAMERA HEAD¿ ON CCU AND AN ERROR CODE 0125. NO PATIENT CONSEQUENCES. THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10693204 ↗
• MalfunctionNov 21, 2019Intermittent Capture; Intermittent Capture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A DIAGNOSTIC LAPAROSCOPY, AFTER INSTALLATION, IT WAS OBSERVED THAT SOME PINKISH AND PURPLE COLORS WERE GETTING RELAYED IN THE SCREEN AND THAN THE OVB1 CAMERA CONTROL UNIT STOPPED WORKING. THERE WAS ANODELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356450 ↗
• MalfunctionOct 17, 2019Intermittent Loss of Power; Intermittent Loss of Power

  DEVICE REPORT FROM MITEK (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING A HYSTEROSCOPY WHEN SWITCHING ON THE OVB1 CAMERA CONTROL UNIT AND THE TCK1 HD CAMERA HEAD IT SHOWED AN ERROR 0128 AND THE CAMERA WENT OFF. IT IS UNKNOWN IF THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT OR IF IT WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR A TCK1 HD CAMERA HEAD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203470 ↗
• MalfunctionSep 13, 2019Intermittent Loss of Power; Intermittent Energy Output; Intermittent Loss of Power; Intermittent Energy Output

  IT WAS REPORTED BY THE SALES REP THAT BEFORE AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE POWER BUTTON ON THE OVB1 CAMERA CONTROL UNIT DEVICE WAS WORKING INTERMITTENTLY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9033710 ↗
• MalfunctionMay 9, 2019Intermittent Capture; Intermittent Capture

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA E-MAIL THAT DURING LAPAROSCOPY, IT WAS OBSERVED THAT THE IMAGE WOULD GO OFF COMPLETELY DURING MANIPULATION OF THE CAMERA; AND THEN THE GREEN INDICATOR THAT SHOWED THAT THE CAMERA WAS WORKING WOULD GO OFF WHEN THE IMAGE DISAPPEARED BUT THEN THE IMAGE WOULD COME ON AGAIN. IT WAS FURTHER REPORTED THAT THE BASE UNIT WOULD SOMETIME AUTOMATICALLY GO OFF ALTHOUGH THE IMAGE MAY STILL BE SEEN BUT THE PHOTO ALSO DID NOT GET CAPTURED. AS A RESULT, THERE WAS A SURGICAL DELAY OF HALF AN HOUR AS A STANDBY SYSTEM WAS AVAILABLE FOR USE. THE SURGERY WAS NOT COMPLETED AS THE DEVICE HAS SHIFTED FROM THE OTHER CENTER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8594757 ↗
• MalfunctionMay 3, 2019Intermittent Energy Output; Intermittent Energy Output

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE CAMERA HAS BROKEN IN BETWEEN THE SURGERY. IT WAS ALSO REPORTED THAT THE CAMERA HAS BEEN BROKEN MULTIPLE TIMES IN BETWEEN THE SURGERY. IT WAS ALSO REPORTED THAT THIS HAS OCCURRED WITH DIFFERENT UNITS WHICH CAUSES SAME RESULT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577730 ↗
• MalfunctionApr 15, 2019Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT TCK1 HD CAMERA HEAD AND OVB1 CAMERA CONTROL UNIT ARE NOT WORKING. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A 10 MINUTE SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Not Applicable

  MAUDE report 8514087 ↗
• InjuryApr 11, 2019Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE OVB1 CAMERA CONTROL UNIT IN BETWEEN THE SURGERY, THE CAMERA STOPPED GIVING OUTPUT ON THE SCREEN. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THAT THE CAMERA CONTROL UNIT STOPPED WORKING DURING THE PROCEDURE. THE PROCEDURE WAS CANCELLED DUE TO THIS MALFUNCTION.

  Patient problems: No Code Available

  MAUDE report 8505981 ↗
• MalfunctionMar 18, 2019Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING THE SURGERY BY USING OVB1 CCU AND TCK1 HD CAMERA HEAD, THE CAMERA STOPPED GIVING OUTPUT ON THE SCREEN. ADDITIONAL INFORMATION RECEIVED FORM THE AFFILIATE REPORTED THAT THE PROCEDURE WAS CANCELLED BECAUSE THE CAMERA DID NOT WORK AND AN ALTERNATIVE DEVICE WAS NOT AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8429719 ↗
• InjuryFeb 12, 2019Intermittent Continuity; Intermittent Continuity

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THEIR OVB1 CAMERA HAD STOPPED GIVING OUTPUT ON ITS SCREEN DURING THE SURGERY. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 01/15/19 REPORTING THAT THERE WAS A SURGICAL DELAY OF 20 TO 30 MINUTES AND THE SURGERY HAD TO BE CALLED OFF DUE TO THE MALFUNCTION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 01/16/19 STATING THAT THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED.

  Patient problems: Not Applicable

  MAUDE report 8332975 ↗
• InjuryNov 19, 2018Image Display Error/Artifact; Computer Operating System Problem; Image Display Error/Artifact; Computer Operating System Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT AN ERROR 129 SHOWED UP ON THE CONSOLE. AS A RESULT, THERE WAS A DELAY OF TWO HOURS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT DURING THE TWO HOUR SURGICAL DELAY, THE AFFILIATE INDICATED THAT THE SURGEON HAD TO SWITCH TO AN OPEN SURGERY TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ALTERNATIVES READILY AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WERE NO PATIENT IMPACT. HOWEVER, IT WAS NOT REPORTED IF THERE WERE ANY MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 8083964 ↗