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

Model Number	EPK-I7010
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
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.
Additional Manufacturer Narrative
Evaluation summary: the processor causes an abnormality in the image.Although, the cause could not be determined, from the information obtained.The possible cause was a failure of the processor board.Correction information: h6: coding changed, based on the investigation result.

• 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: 12425586
• Report Number: 9610877-2021-00658
• Device Sequence Number: 3308457
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 08/05/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/07/2022
• 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