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

Model Number EPK-I7010-US

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, "lamp issue is intermittent/making clicking noises" involving pentax model epk-i7010-us/serial (b)(4).No further information was provided.Pentax has made a good faith effort attempt to collect additional information from the facility.No further information has been received to date.The device was returned to pentax.Pentax service inspectional findings included: lamp power supply unit lamp not igniting, scope connector handle loose, lamp not igniting.Repairs were performed on the device which included replacement of the following components: lamp power supply-u w/bush type-d.The device was shipped back to the facility.

Manufacturer Narrative

Evaluation summary: we have replaced the parts, but have not been able to identify the cause.The presumed cause is that the lamp does not light due to failure or deterioration, and the igniter sends voltage multiple times to light it.

• Brand Name: PENTAX
• Type of Device: 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: 12249363
• MDR Text Key: 282342876
• Report Number: 9610877-2021-00360
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333223794
• UDI-Public: 04961333221141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: EPK-I7010-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1