MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO PROCESSOR

Model Number	EPK-I5500C
Medical Device Problem Codes	No Display/Image (1183); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Customer reported that a double procedure was being performed and in between the egd and the colonoscopy, while the tech was doing bedside pre-clean of the egd scope, the processor went into sleep mode on it's own.The touch panel and procedure monitors went completely black.Fortunately this incident occurred while the scope was outside of the patient.They were able to press the power button and bring up the processor and monitors.This event occurred at the time of before use.There was no report of patient harm.
Additional Manufacturer Narrative
Correction information: h6: coding changed, based on the investigation result.Evaluation summary: the cause of the event was investigated, but no abnormalities were found in the product.In addition, dhr's investigation also confirmed, that all tests were passed in the inspection at the time of shipment.Even if the event occurs, the device can be started by pressing the power switch again, so safety is not affected.
Additional Manufacturer Narrative
Correction information: g2: report source (checked "foreign", so fixed it.).

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 15415729
• Report Number: 9610877-2022-00561
• Device Sequence Number: 6526150
• Product Code: PEA
• UDI-Device Identifier: 04961333233670
• UDI-Public: 04961333233670
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EPK-I5500C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 08/23/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/22/2022; 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown