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

Model Number EPK-I7010

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

On (b)(6), the distributor purchased the epk-i7010 s/n: (b)(4) from beijing stone jiahe company.On (b)(6) 2021, epk-i7010 s/n: (b)(4) arrived at office.On (b)(6) 2021, the distributor opened the box and inspected the processor found that horizontal lines on the image of touch panel.They tried 5 times; the defect happened at 1st (2 mins), 4th time, 5th time (3 mins after power-on for 5 mins).This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.This device is not distributed in us so that unique identifier is blank.This device is classified as import for export, therefore 510k is not applicable.Model epk-i7010-us is available in the usa with a 510k number k182004.

Manufacturer Narrative

Evaluation summary: the defect happened at distribuor office.And before use.The processor has been replaced.Correction information: h6: coding changed, based on the investigation result.

• Brand Name: PENTAX
• Type of Device: 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: 13040456
• MDR Text Key: 287035173
• Report Number: 9610877-2021-01924
• Device Sequence Number: 1
• Product Code: PEA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPK-I7010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1