MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL)

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
Event or Problem Description
Pentax medical was made aware of a complaint which occurred in (b)(6).The customer reported a bluish/greenish screen and they couldn't get it to go back to normal coloring 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.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
(b)(4).The customer owned processor has not been returned for evaluation as of 26-jan-2022.The user facility contacted pentax medical customer service and let them know on 29-dec-2021 that they would not need a loaner as they were able to resolve the settings and will not be sending the video processor for evaluation or repair.Multiple good faith effort requests for additional information was made with no additional information being provided as of 26-jan-2022.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.If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Evaluation summary: this may be due to the disconnection of the cmos cable due to repeated use.Correction information: g6: follow up #1 h2: type of follow up h3: device evaluated h6: coding changed based on the investigation result.H4: device manufacture date.

• Brand Name: PENTAX
• Common Device Name: OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL)
• 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: 13359906
• Report Number: 9610877-2022-00126
• Device Sequence Number: 14636956
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,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: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2018
• 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