FDA Adverse Event Malfunction Summary report: N

PENTAX MEDICAL VIDEO PROCESSOR EPK-I5010

MDR report key: 23187765 · Received October 1, 2025

Report

Report Number
23187765
Event Type
Malfunction
Date Received
October 1, 2025
Date of Event
May 13, 2025
Report Date
September 9, 2025
Manufacturer
HOYA CORPORATION PENTAX DIVISION
Product Code
PEA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PT CONSENTED FOR AN EGD [ESOPHAGOGASTRODUODENOSCOPY] AND COLONOSCOPY, DURING EGD (SCOPE [REDACTED]), SCREEN LOST IMAGE MULTIPLE TIMES. NURSING STAFF (MYSELF) HAD TO TAKE THE SCOPE OUT OF THE PROCESSOR (EPK) MACHINE AND PLACE IT BACK IN AND THEN ABOUT 3 SECONDS LATER, IMAGE WILL COME BACK UP. DURING EGD, SCOPE HAD TO BE RESET INTO PROCESSOR ABOUT 4 TIMES BEFORE PROCEDURE CAN BE COMPLETED. DURING COLONOSCOPY, SCREEN ALSO LOST IMAGE AT THE BEGINNING. DR. [REDACTED] WAS REQUESTING FOR MACHINE TO BE REPLACE, AT THE TIME, WRITER INFORMED HIM THAT THERE IS NO OTHER MACHINE TO REPLACE IT WITH. WRITER OBSERVED DR. [REDACTED] MOVE THE HAND PIECE OF THE COLON SCOPE (SCOPE # [REDACTED]), WHICH CAUSED MOVEMENT OF THE PART CLOSEST TO THE PROCESSOR, LEADING TO AN IMAGE LOST ON THE SCREEN. WRITER PLACED HAND ON THE MOBILE PART OF THE SCOPE AND HELD IT STEADY AGAINST THE PART THAT DIRECTLY PLUGS INTO THE PROCESSOR AND NOTED THAT THERE IS NOT LONGER LOST OF IMAGE. WRITER INFORMED MD NOT TO MOVE THE HAND PIECE TOO MUCH. MD APPEARED IRRITATED AND ASKED IF HE SHOULD CANCEL THE PROCEDURE, TO WHICH WRITER REPLIED THAT "IT WOULD BE UP TO MD TO DECIDE". PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR IMAGE LOST. EARLIER IN THE DAY, A COLONOSCOPY WAS COMPLETED ON A DIFFERENT PATIENT, [REDACTED] (MEDICAL RECORD NUMBER [REDACTED]) A DIFFERENT SCOPE HAD MULTIPLE IMAGE LOST DURING THE COLONOSCOPY TO WHICH [REDACTED] AND MYSELF HAD TO TAKE THE SCOPE OUT AND PLACE BACK INTO PROCESSOR TO OBTAIN IMAGE AGAIN. ORIGINALLY WRITER THOUGHT IT WAS THE SCOPE, THEREFORE A WORK ORDER TO BIOMED WAS PLACED FOR SCOPE NUMBER [REDACTED].

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2154406 PENTAX MEDICAL VIDEO PROCESSOR EPK-I5010 ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT PEA HOYA CORPORATION PENTAX DIVISION EPK-I5010

Patients

Seq Age Sex Outcome Treatment
1 60 YR Unknown