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

Model Number EPK-I5010

Device Problem Optical Problem (3001)

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

Event Date 06/04/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of a report for an event which occurred in the usa stating "customer reported lines across the screen turned on lamp and full white out screen can see horizontal lines on the screen.Also, pink screen intermittently during procedures".Furthermore, black on side of monitors went pink too" involving pentax model epk-i5010/serial (b)(4).No further information was provided at the time of the report.The device was returned to pentax medical on 06/14/2021.Pentax service inspectional findings included: electrical connector with wiring intermittent connection, scope connector handle loose, air socket tube leaking and limit switch actuator plate bent.Repairs were performed on the device which included replacement of the following components: cable to limit sw, scope connector assy, and air outlet assy.The device was returned to the customer on 06/24/2021.This device has been routinely serviced at a pentax facility since the device was put into service.This event meets the requirements for fda reportability.

Manufacturer Narrative

Pentax medical will be providing supplemental information after follow up on the event.(b)(4).This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

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 (health effect clinical code,health effect impact code).Additional information: h4:device manufacture date.

• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12112438
• MDR Text Key: 281018088
• Report Number: 9610877-2021-00171
• Device Sequence Number: 1
• Product Code: ODG
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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-I5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1