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

Model Number	EPK-I7010
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Correction information: g4:premarket identification pma/510(k).G6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: the reason why the white lines that move up and down are displayed on the touch screen is unknown, but it is assumed that the white lines are displayed due to the failure of the touch screen board or screen.

• 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 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12478817
• Report Number: 9610877-2021-00860
• Device Sequence Number: 14405791
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 08/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2020
• 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