VIDEO LARYNGOSTROBOSCOPE VLS-1070STKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333240371), received between Aug 27, 2021 and Dec 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2021No Display/Image; No Display/Image

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO SCOPE VLS-1070STK. IN THE EVENT REPORTED, THE USER STATES THAT THERE NO VIDEO IMAGE. THE TIMING OF THE EVENT IS UNKNOWN. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT. THIS EVENT MEETS THE REQUIREMENT FOR FDA REPORTABILITY; THEREFORE, SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010681 ↗
• MalfunctionAug 27, 2021No Display/Image; No Display/Image

  PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE UNITED STATES STATING, " NO VIDEO IMAGE" INVOLVING PENTAX MODEL VLS-1070STK, SERIAL NUMBER (B)(4). THE EVENT WAS REPORTED TO OCCUR IN THE OPERATING ROOM, BEFORE USE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 30-JUL-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT OF IMAGE BLACKOUT AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: INSERTION TUBE SEVERE CRUSH AT STAGE 1, PASSED WET LEAK TEST, LONG UMBILICAL CABLE BUCKLE AT JUNCTION, LONG UMBILICAL CABLE CRUSH, PASSED DRY LEAK TEST, SHORT UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, SHORT UMBILICAL CABLE CRUSH, LIGHT CARRYING BUNDLE HAS LESS THAN 70% TRANSMISSION, # 4 REMOTE CONTROL BUTTON COVER CRACKED, HOLE IN # 1 REMOTE CONTROL BUTTON COVER, INSERTION TUBE SEVERE CRUSH AT STAGE 2, INSERTION TUBE SEVERE CRUSH AT STAGE 3. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, DISTAL END W/CCD-M PB-FREE/NTSC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377806 ↗