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

Model Number	EPK-I5500C
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was no report of patient harm.The time of event is unknown.No known adverse event.Refer to expiration date as complaint notification date.Customer reported he & his other physicians have noticed a slow deterioration of image quality since the install.
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.This device is classified as import for export, therefore 510k is not applicable.
Additional Manufacturer Narrative
Correction information 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 gfe (good faith effort) was performed, but no response was obtained, and the device did not return, so the cause is unknown.Regarding the content of the image abnormality, it was determined that it was not due to design/manufacturing because there was no abnormal increase in the number of image abnormalities.
Additional Manufacturer Narrative
Evaluation summary: it is possible that the event was caused by the deterioration of image-related parts due to use, but it has not been determined.
Additional Manufacturer Narrative
Correction information g4:.Premarket identification pma/510(k) g6: follow up #2 h2:if follow-up, what type?.

• 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: 13657044
• Report Number: 9610877-2022-00337
• Device Sequence Number: 14776111
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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-I5500C
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 02/11/2022; 02/11/2022; 02/11/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 09/22/2022; 12/02/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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