MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; OPTIVISTA EPK-I7010 HD VIDEO PROCESSOR

Model Number	EPK-I7010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Optical Problem (3001); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported when testing the equipment, the video image is too bright.This event occurred at the time of installation.There was no report of patient harm.
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Evaluation summary: according to the contents of the report, it was speculated that the fitting of the connection part of the product became loose due to unintended usage (used to connect an aer that delivers a high-temperature disinfectant solution and an endoscope), and that the tube came off when the product was subsequently removed.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
Additional Manufacturer Narrative
Evaluation summary: it was assumed that the feather diaphragm could not be controlled due to temporary dimming failure caused by abnormal operation of the feather diaphragm (iris) due to an accidental failure of the process board (e.G., temperature rise in the processor).A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 28-apr-2022 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 29-apr-2022.

• Brand Name: PENTAX
• Common Device Name: OPTIVISTA EPK-I7010 HD VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• 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: 16230830
• Report Number: 9610877-2023-00005
• Device Sequence Number: 6475045
• Product Code: ODG
• UDI-Device Identifier: 04961333221141
• UDI-Public: 04961333221141
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K182004
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2023

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-I7010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023; 01/13/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 04/07/2023; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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