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

Model Number	EPK-I7010
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax medical was made aware of an event which occurred in the united states involving pentax video processor epk-i7010-us sn: (b)(4).The customer stated that there is no video connection-error message.There was no adverse event reported with this complaint.Pentax customer service issued return material authorization (b)(4) for the return of the device for further evaluation.The device was returned to pentax medical service facility for further evaluation on service order (b)(4) where the incoming quality control inspector confirmed the user narrative.The inspector also found additional defects.Additional findings: lamp power supply unit lamp not igniting, limit switch actuator plate(2) bent, ball plunger damaged, electrical connector with wiring intermittent connection, scope connector handle loose, air socket tube leaking, customer complaint confirmed.The device was repaired, and final quality control checked and returned to the user on delivery note (b)(4).Parts replaced: scope connector assy, cable to limit sw, air outlet assy, ball plunger, lamp power supply-u w/bush type-d.A review of the service history indicates that the device was not routinely serviced at pentax service facility since installation on 31aug2017.
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.There is a similar model available for sale in the united states epk-i7010-us with a 510k #k182004 (b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Additional 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
• Common Device Name: 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: 12242165
• Report Number: 9610877-2021-00336
• Device Sequence Number: 3681437
• Product Code: PEA
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/18/2022
• Date Device Manufactured: 07/21/2017
• 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