NA 242400Recalls & reported problems
Medos International Sàrl · TCK1 HD Camera Head, C-Mount · Class 1
Quick summary
This Medos TCK1 HD camera head is the endoscopic video camera used to view surgery inside the body. The 30 reports mostly describe the camera cutting out, losing power, or dropping the video signal mid-procedure, sometimes forcing delays or cancellations; 4 reports mention injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886705026258), received between Dec 24, 2017 and Aug 17, 2020 — classified as 4 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Intermittent Continuity” (10 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
Device problems
- Intermittent Continuity10
- Intermittent Loss of Power7
- Failure to Power Up3
- Intermittent Capture2
- Operating System Becomes Nonfunctional2
- Poor Quality Image2
- Break1
- Component or Accessory Incompatibility1
Patient problems
- No Consequences Or Impact To Patient22
- Not Applicable6
- No Code Available3
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2020Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED BY DISTRIBUTOR VIA COMPLAINT SUBMISSION TOOL THAT PRE-OPERATIVELY TO A KNEE ARTHROSCOPY, A TCK1 HD CAMERA HEAD WAS FAULTY, CAMERA STOPPED WORKING AND THERE WAS NO DISPLAY SEEN. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10416234 ↗MalfunctionJan 31, 2020Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED BY THE AFFILIATE BY CUSTOMER'S EMAIL THAT DURING PRE SURGERY CHECK THE TCK1 HD CAMERA HEAD GETS RELAYED SOMETIMES AND GOES OFF SOMETIMES AND DOES NOT WORK PROPERLY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9655642 ↗MalfunctionJan 3, 2020Intermittent Capture; Intermittent Capture
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DISPLAY OF THE TCK1 HD CAMERA HEAD WAS GETTING LOST EVERY TWO SECONDS WHEN THE HEAD WAS CONNECTED TO THE CONTROL UNIT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS 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 9546624 ↗MalfunctionDec 12, 2019Intermittent Continuity; Component or Accessory Incompatibility; Intermittent Continuity; Component or Accessory Incompatibility
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN HYSTEROSCOPY PROCEDURE THE TCK 1HD CAMERA HEAD STOPPED WORKING WITH NO DISPLAY ON THE MONITOR AND A MESSAGE ON THE MONITOR AS "CAMERA NOT CONNECTED". THE PROCEDURE WAS DELAYED BY 15-20 MINUTES.
Patient problems: Not Applicable
MAUDE report 9460356 ↗MalfunctionOct 22, 2019Image Display Error/Artifact; Operating System Becomes Nonfunctional; Image Display Error/Artifact; Operating System Becomes Nonfunctional
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THAT THE TCK 1 HD CAMERA HEAD IS NOT WORKING AND IS DEFECTIVE. THE IMAGE IS FLICKERING. THIS FAILURE WAS FOUND DURING SURGERY. THIS REPORT IS FOR ONE (1) TCK1 HD CAMERA HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9218290 ↗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 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9203413 ↗MalfunctionOct 8, 2019Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT WHILE THEY WERE CHECKING AT THE HOSPITAL THE LAPAROSCOPY SET FOR 3 SURGERIES THAT ARE SCHEDULED FOR (B)(6) 2019. THEY SAW THE ERROR MESSAGE "INVALID SENSOR ID ERROR 0128" AND "NO HSYNC LOCK ERROR 0129" ON THE CCU DISPLAY WITH NO IMAGE OR VIDEO ON THE MONITOR. THIS CAUSE THE TCK1 HD CAMERA HEAD, C-MOUNT TO STOPPED WORKING. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A DEMO/STANDBY CAMERA HEAD WAS PROVIDED TO THE HOSPITAL SO ADDITIONAL PROCEDURES COULD TAKE PLACE. THE AFFILIATE ALSO REPORTED THAT AN ALTERNATIVE DEVICE WAS NOT READILY AVAILABLE AND THE FAILURE WAS NOTED PRIOR TO ANY PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9169184 ↗MalfunctionOct 2, 2019Break; Image Orientation Incorrect; Poor Quality Image
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING THE SURGERY WHEN THE TCK1 HD CAMERA HEAD, C-MOUNT IS CONNECTED TO THE CONSOLE, IMAGES FLUCTUATES WITH INTERRUPTIONS AND DISTORTIONS AND WITH NO CONSTANT PROPER IMAGE SIGNAL TO BE ABLE TO PERFORM THE SURGERY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAYED WAS REPORTED. NO ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SURGERY HAD TO CANCELLED AS THE CAMERA UNIT WAS NOT WORKING DUE TO THE HEAD FAILURE IMAGES WERE FLUCTUATING AND DISTORTED BECAUSE AN ALTERNATIVE PRODUCT WAS NOT READILY AVAILABLE. THE AFFILIATE ALSO REPORTED THE REPORTED MALFUNCTION WAS FOUND DURING PRE-OPERATION SET UP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9145730 ↗MalfunctionSep 30, 2019Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE THE TCK1 HD CAMERA HEAD STOPPED RELAYING THE IMAGE OR VIDEO ON TO THE ATTACHED MONITOR AND DISPLAYED. THE SURGEON MANAGED TO COMPLETE THE SURGERY BY USING ANOTHER ALTERNATIVE LAP SET AVAILABLE WITH THE HOSPITAL. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE TWO DEVICES WERE INVOLVED IN TWO SEPARATE INCIDENTS. THE AFFILIATE LATER REPORTED THE ALLEGED MALFUNCTION WAS FOUND DURING A PCNL PROCEDURE, THIS PARTICULAR CAMERA STOPPED WORKING THE CASE WAS COMPLETED BECAUSE HOSPITAL IS EQUIPPED WITH ANOTHER LAPAROSCOPY SET. THE SURGICAL TEAM WAS ABLE TO REPLACE THE MALFUNCTIONING CAMERA AN ALTERNATIVE SET. IT WAS ALSO REPORTED THE ALLEGED MALFUNCTION CAUSED A 10 TO 15 MINUTE SURGICAL DELAY WHICH DID NOT CAUSE ANY PATIENT OR USER HARM.
Patient problems: Not Applicable
MAUDE report 9136187 ↗MalfunctionSep 6, 2019No Display/Image
IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT DURING A CYSTOSCOPY THE TICK1 HD CAMERA HEAD WAS BLANK . THERE WAS NO IMAGE AFTER PUTTING IT ON FOR FEW MINUTES DURING THE SURGERY. THE CASE WAS IDENTIFIED INTRA-OP. THERE WAS A SURGICAL DELAY OF ONE HOUR. THERE WAS NO PATIENT CONSEQUENCES. THE SURGEON MANAGED THE CASE AND IT WAS COMPLETED. THERE WAS NO ALTERNATIVE PRODUCT AVAILABLE.
Patient problems: Not Applicable
MAUDE report 8972711 ↗InjuryAug 30, 2019Intermittent Continuity; Intermittent Continuity
DOCTOR CALLED TO INFORM THAT IN THE MIDDLE OF A SURGERY IMAGE WAS NOT GETTING DISPLAYED ON THE MONITOR. INVALID CAMERA HEAD ERROR 0125&OUR LAPAROSCOPY SET STOPPED WORKING AND DOCTOR MANAGED TO COMPLETE THE SURGERY BY CONVERTING IT INTO AN OPEN SURGERY. DURING A LAPAROSCOPY APPENDIX SURGERY CAMERA STOPPED RELAYING THE IMAGE OR VIDEO ON TO THE ATTACHED MONITOR AND DISPLAYED INVALID CAMERA HEAD ERROR 0125. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THERE WAS NOT MUCH OF A SURGICAL DELAY BECAUSE THE SURGERY WAS CONVERTED FROM A LAPAROSCOPY SURGERY TO AN OPEN SURGERY. THE AFFILIATE ALSO REPORTED THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Code Available
MAUDE report 8951490 ↗InjuryAug 20, 2019Intermittent Continuity; Intermittent Continuity
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A LAPAROSCOPY APPENDIX SURGERY THE TCK 1 HD CAMERA HEAD STOPPED RELAYING THE IMAGE OR VIDEO ON TO THE ATTACHED MONITOR. IT TURNED INTO A MULTICOLOR STRIPPED SCREEN. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A SURGICAL DELAY OF 5 MINUTES AND THE NEED TO CONVERT THE PROCEDURE FROM AN ARTHROSCOPIC TO OPEN PROCEDURE. THE AFFILIATE REPORTED THERE WERE NO KNOWN PATIENT OR USER HARM AND THE PROCEDURE WAS COMPLETED BY CONVERTING TO AN OPEN PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO ALTERNATIVE PRODUCTS AVAILABLE AT THE TIME.
Patient problems: No Code Available
MAUDE report 8911443 ↗MalfunctionJul 11, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT THE HD CAMERA HEAD HAS A MALFUNCTION. THE CAUSE IS UNKNOWN. IT WAS UNKNOWN ABOUT THE PATIENT STATUS/ OUTCOME/ CONSEQUENCES. IT WAS UNKNOWN IF THERE WAS ANY MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) WAS REQUIRED OR WHETHER THE PATIENT WAS PART OF A CLINICAL STUDY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8782661 ↗MalfunctionMay 9, 2019Intermittent Capture; Intermittent Capture
THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN INDIA VIA E-MAIL THAT DURING LAPROSCOPY, 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 8594758 ↗MalfunctionMay 2, 2019Sensing Intermittently; Sensing Intermittently
IT WAS REPORTED THAT THE TCK1 HD CAMERA HEAD HAS INTERMITTENTLY IMAGE THAT IS GETTING FLICKERED AND COLOR BARS ARE APPEARING. THE EVENT OCCURRED PRE-OPERATIVE OF CYSTOSCOPE (UROLOGY). THERE WAS NO IMPACT TO THE PATIENT. CASE WAS COMPLETED WITH AN ALTERNATIVE PRODUCT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8574256 ↗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 8513955 ↗MalfunctionMar 28, 2019Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S TCK1 CAMERA HEAD HAD POOR IMAGE QUALITY AND THE IMAGE WAS CUTTING OUT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE DEVICE IS BEING RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8460252 ↗InjuryMar 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 8429718 ↗MalfunctionMar 11, 2019Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED BY THE AFFILIATE THAT THETCK1 HD CAMERA HEAD IMAGE IS FLICKERING INTERMITTENTLY AND COLOR BARS ARE APPEARING. THE EVENT OCCURRED PRE-OPERATIVELY. THE INTENDED PROCEDURE WAS A TURP. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. THE EXISTING CAMERA WAS USED TO COMPLETE THE PROCEDURE; AN ALTERNATE PRODUCT WAS READILY AVAILABLE. NO SURGICAL INTERVENTION IS PLANNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8407826 ↗MalfunctionJan 29, 2019Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMAGE ON THE TCK1 HD CAMERA HEAD DEVICE WAS CUTTING IN AND OUT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
MAUDE report 8286648 ↗MalfunctionJan 4, 2019Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THERE WAS FREQUENT IMAGE DISTURBANCE WITH THEIR TCK1 HD CAMERA HEAD DURING PROCEDURES SINCE LAST THREE MONTHS. AFFILIATE MENTIONED THAT INITIALLY THE PROBLEM WAS WITH CCU POWER SUPPLY (CCU FREQUENTLY GETTING OFF) AND WAS REPLACED THE SAME, BUT AGAIN THE MACHINE STARTED GIVING THE IMAGE DISTURBANCE TILL DATE.. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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
MAUDE report 8218462 ↗MalfunctionJan 4, 2019Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THERE WERE FREQUENT IMAGE DISTURBANCE ON TCK1 HD CAMERA HEAD DURING PROCEDURES SINCE LAST THREE MONTHS. AFFILIATE STATED THAT IT WAS THE PROBLEM WITH CCU POWER SUPPLY INITIALLY (CCU FREQUENTLY GETTING OFF) AND WAS REPLACED THE SAME HOWEVER THE MACHINE STARTED GIVING THE IMAGE DISTURBANCE AGAIN TILL DATE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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: No Consequences Or Impact To Patient
MAUDE report 8218433 ↗MalfunctionDec 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE CAMERA HEAD WOULD INTERMITTENTLY DISPLAY THE IMAGE AS IF IT WAS GETTING FLICKERED FOR A MOMENT BY THE CABLE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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: No Consequences Or Impact To Patient
MAUDE report 8182522 ↗MalfunctionNov 30, 2018Failure to Power Up; Failure to Power Up
ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 18NOVEMBER2018: THE ISSUES WAS DETECTED PRE-OPERATIVELY ON (B)(6) 2018. THERE WAS NO PROCEDURE OR PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8121413 ↗MalfunctionNov 30, 2018Failure to Power Up; Failure to Power Up
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE TCK1 HD CAMERA HEAD DEVICE WAS NOT SENSING THE CONTROL UNIT. ACCORDING TO THE REPORTER, THERE WAS AN OUT OF BOX FAILURE. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8119856 ↗
Other CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO devices
All CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO devices →Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.