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

Model Number	EPK-I5010
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k continued: import for export.(b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint on 02-dec-2020 stating "during pre-inspection light bulb was replaced and sparks coming out when unit is turned on and lamp does no to come on" involving pentax medical video processor, model epk-i5010, serial number (b)(4).No other information was provided at the time of the report.The customer owned video processor was returned to pentax medical for evaluation on 14-dec-2020.The processor was inspected by pentax medical service technician under service order (b)(4) and the technician documented the following inspection findings on 15-dec-2020: lamp incorrectly installed, limit switch actuator plate(2) bent, connecter mounting plate bent, ball plunger damaged, air socket tube leaking, electrical connector with wiring intermittent connection, scope connector handle loose.The device underwent repairs including the following components: ball plunger, connector cam ring, scope connector assy, cable to limit sw.Multiple good faith effort attempts were made to the customer to gather additional information for the event on 07-dec-2020, 10-dec-2020, and 15-dec-2020, and the customer responded only confirming that the failure occurred during pre-inspection checks and it was removed from service and called in to pentax medical at that time.The video processor was delivered to the customer on (b)(6) 2020 under delivery order (b)(4).
Additional Manufacturer Narrative
Evaluation summary: i replaced the part, but i could not identify the cause.The lamp may have deteriorated or malfunctioned.Since the lamp did not light up, the ignition device was activated several times, and it is believed that the spark flew with the sound.Correction information: g4: premarket identification pma/510(k); g6: follow up #1; h2: type of follow up; h6: coding changed based on the investigation result.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: 11102389
• Report Number: 9610877-2020-00185
• Device Sequence Number: 4037145
• Product Code: PEA
• UDI-Device Identifier: 04961333240227
• UDI-Public: 04961333240227
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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-I5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown