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

Model Number	EPK-I7010
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax medical was made aware of an event which occurred in the pai region involving pentax video processor epk-i7010.In the event reported, the user states that the processor does not work, they tried restarting multiple times.The timing of the event was in the procedure room before use.There was no adverse event reported with this complaint.No other information provided with this complaint.
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Similar model pk-i7010-us is available in the usa with a 510k number k182004.The device was received at pentax medical for further evaluation on service order (b)(4) for further evaluation.The device was inspected where the user narrative was confirmed.The inspection findings are as follows: pcb for pre-process scope not recognized, customer complaint confirmed, pre-process pcb no scope image, scope connector handle loose.The device is in the process of being repaired and will be returned to the user upon completion.If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Evaluation summary: when it was turned on, the processor before use.It was not booted properly.I tried many times, but no improvement.There was no information leading to identification of the cause from the investigation results in the repair.It is presumed, to be a processor board failure.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: 13191108
• Report Number: 9610877-2022-00100
• Device Sequence Number: 17244477
• Product Code: PEA
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K150618
• 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,User Facility,Company Representative,Distributor
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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