VIDEO PROCESSOR EPK-I7010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04961333232604), received between Jul 28, 2021 and Jan 26, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2022Poor Quality Image; Poor Quality Image

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN (B)(6). THE CUSTOMER REPORTED A BLUISH/GREENISH SCREEN AND THEY COULDN'T GET IT TO GO BACK TO NORMAL COLORING INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359906 ↗
• MalfunctionJan 9, 2022No Display/Image; Loose or Intermittent Connection; No Display/Image; Loose or Intermittent Connection

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES STATING THERE WAS NO IMAGE INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, 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. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13201357 ↗
• MalfunctionJan 7, 2022No Display/Image; Optical Problem; No Display/Image; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO PROCESSOR EPK-I7010. IN THE EVENT REPORTED, THE USER STATES THAT THE PROCESSOR DOES NOT WORK, THEY TRIED RESTARTING MULTIPLE TIMES. THE TIMING OF THE EVENT WAS IN THE PROCEDURE ROOM BEFORE USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191108 ↗
• MalfunctionSep 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES STATING "FRONT PANEL TOUCH SCREEN DAMAGE" INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE CUSTOMER OWNED PROCESSOR HAS NOT BEEN RETURNED FOR EVALUATION AS OF 15-SEP-2021. MODEL EPK-I7010, SERIAL NUMBER (B)(4) HAS NOT BEEN PREVIOUSLY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478817 ↗
• MalfunctionSep 3, 2021Poor Quality Image; Poor Quality Image

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES STATING "POOR IMAGE QUALITY" INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, SERIAL NUMBER (B)(4). THE CUSTOMER STATED WHEN GETS TO PROBATION THE IMAGE TURNS BAD/VERTICAL LINES/AND GREEN IN COLOR. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT/IMPORTANT MEDICAL EVENT. THE CUSTOMER OWNED PROCESSOR HAS NOT BEEN RETURNED FOR EVALUATION AS OF 03-SEP-2021. MODEL EPK-I7010, SERIAL NUMBER (B)(4) HAS NOT BEEN PREVIOUSLY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE 05-MAY-2021. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425586 ↗
• MalfunctionAug 25, 2021No Display/Image; Loose or Intermittent Connection; No Display/Image; Loose or Intermittent Connection

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES STATING "NO IMAGE, SCOPE CUTS OUT, AND PVE CONNECTOR LOOSE FIT" INVOLVING PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, 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 PROCESSOR WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 03-AUG-2021. THE PROCESSOR WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE USER COMPLAINT OF "ELECTRICAL CONNECTOR WITH WIRING INTERMITTENT CONNECTION" AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: SCOPE CONNECTOR HANDLE LOOSE, BALL PLUNGER DAMAGED, LIMIT SWITCH ACTUATOR PLATE(2) BENT. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: SCOPE CONNECTOR ASSY, CABLE TO LIMIT SW, BALL PLUNGER. MODEL EPK-I7010, SERIAL NUMBER (B)(4), HAS BEEN PRVIOUSLY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. ON 19-AUG-2021, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL EPK-I7010, SERIAL NUMBER (B)(4), WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367508 ↗
• MalfunctionAug 6, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  HOLD FOR GN 8-19PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE UNITED STATES STATING THE CUSTOMER OBSERVED ERROR CODE 59-05 ON THE VIDEO PROCESSOR INVOLVING PENTAX MEDICAL VIDEOP PROCESSOR MODEL EPK-I7010-US, SERIAL NUMBER (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER STATED THAT THE MESSAGE IS TO RESTART THE PROCESSOR. THE CUSTOMER INDICATED THAT THE PROCESSOR WAS IMMEDIATELY REMOVED FROM CIRCULATION. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT ATTEMPT VIA EMAIL ON 15-JUL-2021 AND CONFIRMED THAT THE ERROR CODE OCCURRED DURING PRE-INSPECTION CHECK. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 20-JUL-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT WITH AN OPTICAL ENHANCEMENT SYSTEM ERROR AS WELL AS DOCUMENTING THE SCOPE CONNECTOR HANDLE LOOSE. ADDITIONAL COMMENTS: OE MOTOR IS BAD IT DOESN'T SPIN THAT GIVES AN ERROR MESSAGE ON SCREEN AND CAN'T IGNITE THE LAMP EITHIER. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: MECHANICAL CAM UNIT THE ENDOSCOPE IS AWAITING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291626 ↗
• MalfunctionJul 28, 2021No Display/Image; No Display/Image

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE UNITED STATES INVOLVING PENTAX VIDEO PROCESSOR EPK-I7010-US SN: (B)(4). THE CUSTOMER STATED THAT THERE IS NO VIDEO CONNECTION-ERROR MESSAGE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. PENTAX CUSTOMER SERVICE ISSUED RETURN MATERIAL AUTHORIZATION (B)(4) FOR THE RETURN OF THE DEVICE FOR FURTHER EVALUATION. THE DEVICE WAS RETURNED TO PENTAX MEDICAL SERVICE FACILITY FOR FURTHER EVALUATION ON SERVICE ORDER (B)(4) WHERE THE INCOMING QUALITY CONTROL INSPECTOR CONFIRMED THE USER NARRATIVE. THE INSPECTOR ALSO FOUND ADDITIONAL DEFECTS. ADDITIONAL FINDINGS: LAMP POWER SUPPLY UNIT LAMP NOT IGNITING, LIMIT SWITCH ACTUATOR PLATE(2) BENT, BALL PLUNGER DAMAGED, ELECTRICAL CONNECTOR WITH WIRING INTERMITTENT CONNECTION, SCOPE CONNECTOR HANDLE LOOSE, AIR SOCKET TUBE LEAKING, CUSTOMER COMPLAINT CONFIRMED. THE DEVICE WAS REPAIRED, AND FINAL QUALITY CONTROL CHECKED AND RETURNED TO THE USER ON DELIVERY NOTE (B)(4). PARTS REPLACED: SCOPE CONNECTOR ASSY, CABLE TO LIMIT SW, AIR OUTLET ASSY, BALL PLUNGER, LAMP POWER SUPPLY-U W/BUSH TYPE-D. A REVIEW OF THE SERVICE HISTORY INDICATES THAT THE DEVICE WAS NOT ROUTINELY SERVICED AT PENTAX

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

  MAUDE report 12242165 ↗