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
Event or Problem Description
Pentax medical was made aware of a complaint which occurred in the united states stating "no image, scope cuts out, and pve connector loose fit" 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.The customer owned processor was received by pentax medical for evaluation on 03-aug-2021.The processor was inspected by pentax medical service under service order (b)(4) and the technician confirmed the user complaint of "electrical connector with wiring intermittent connection" and also documented the following inspection findings: scope connector handle loose, ball plunger damaged, limit switch actuator plate(2) bent.The device underwent repairs including the following components: scope connector assy, cable to limit sw, ball plunger.Model epk-i7010, serial number (b)(4), has been prviously serviced at a pentax facility since the device was put into service.On 19-aug-2021, a device history record(dhr) review for model epk-i7010, serial number (b)(4), was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 20-oct-2017 under normal conditions.The processor g-board was reworked as the device repeats fully open and fully closed when the aperture is fully opened.It passed all required inspections, and was released accordingly without concessions.The dates of approval for shipment and actual date shipped were confirmed for 20-oct-2017.The processor was repaired and approved by final qc on 12-aug-2021 and was delivered to the customer under delivery order (b)(4).
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

• 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
• MDR Report Key: 12367508
• Report Number: 9610877-2021-00529
• Device Sequence Number: 3887601
• Product Code: ODG
• UDI-Device Identifier: 04961333232604
• UDI-Public: 04961333232604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 08/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1