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

Model Number	EPK-I7010-US
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
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Hold for gn 8-19 pentax medical became aware of a report for an event which occurred in the united states stating the customer observed error code 59-05 on the video processor involving pentax medical videop processor model epk-i7010-us, serial number (b)(4).No further information was provided.The customer stated that the message is to restart the processor.The customer indicated that the processor was immediately removed from circulation.The issue was identified prior to use.The user facility responded to a good faith effort attempt via email on 15-jul-2021 and confirmed that the error code occurred during pre-inspection check.The customer owned endoscope was received by pentax medical for evaluation on 20-jul-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint with an optical enhancement system error as well as documenting the scope connector handle loose.Additional comments: oe motor is bad it doesn't spin that gives an error message on screen and can't ignite the lamp eithier.The device underwent repairs including the following components: mechanical cam unit the endoscope is awaiting repair and approval by final qc as 06-aug-2021.Model epk-i7010-us, serial number (b)(4).Has been routinely serviced at a pentax facility since the device was put into service.

• 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
• MDR Report Key: 12291626
• Report Number: 9610877-2021-00425
• Device Sequence Number: 17128139
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1