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

Model Number	EPK-I7010
Medical Device Problem Codes	No Display/Image (1183); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model epk-i7010-us available in the united states with a 510k number k182004.International medical device regulators forum (imdrf) adverse event reporting: (b)(4).The customer owned processor was received by pentax medical for evaluation on 16-dec-2021.The processor was inspected by pentax medical service under service order (b)(4) and the technician confirmed the user complaint and documented the following inspection findings: process pcb digital video failure, limit switch actuator plate(2) bent, ball plunger damaged, scope connector handle loose, control panel unit physical damage, process pcb software failure, customer complaint confirmed.The technician also noted the process board is bad, has a corrupted software and can't detect the scope.Limiter switch is worn out losing image when scope is tap or move.Bad plunger and loose screws on scope locking assembly.Scratched and couple of small cracked on the control panel cover, possible caused by the strong cleaning chemical.The device underwent repairs including the following components: ctrl panel unit w/front cover, ball plunger, cable to limit sw, pcb for process w7 ntsc.Model epk-i7010, serial number (b)(4), has been routinely been serviced at a pentax facility since the device was put into service.The device is awaiting repair and approved by final qc as of 10-jan-2022.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical was made aware of a complaint which occurred in the united states stating there was no image involving pentax medical video processor model epk-i7010, serial number (b)(4).The event was reported to occur in the operating room, before use.There was no report of death, serious injury or other significant/important medical event.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: PENTAX
• Common Device Name: 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: 13201357
• Report Number: 9610877-2022-00022
• Device Sequence Number: 5860766
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: REFER TO H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2022

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: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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