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

Model Number	EPK-I5010
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On 15-jul-2020 pentax medical received a customer report stating video processor, model epk-i5010, serial number (b)(4) was involved in a malfunction event.The user reported "no image- scope cuts out during procedure that lead to medical intervention of additional anesthesia and a possible delay that put the patient at risk for adverse events." the user facility responded to a good faith effort(gfe) attempt via email on 15-jul-2020 and noted the reported no image occurred during a treatment procedure on (b)(6) 2020.There was no injury reported, but there was a delay in the procedure which resulted in additional anesthesia which the user felt possibly put the patient at risk for an adverse event, although none were reported.The product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replace.The patient information was requested but not provided by the user.The customer owned processor was received by pentax medical for evaluation on 14-jul-2020.The video processor was evaluated and after three days of testing the service repair technician was unable to reproduce the customers reported experience.Since the user contact stated that the control panel is not lighting up and buttons are not responding the service team replaced the sbs board as a preventative measure and documented that the sbc pcb touch panel controls not functioning.On 28-jul-2020, a device history record(dhr) review for model epk-i5010, serial number (b)(4) was performed under ivai-20-070084, the dhr review confirmed the endoscope was manufactured on 01-oct-2015 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 01-oct-2015.Pentax medical model epk-i5010, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2015.The video processor was repaired and returned to the customer on (b)(6) 2020 under delivery number (b)(4).

• 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
• MDR Report Key: 10410760
• Report Number: 9610877-2020-00107
• Device Sequence Number: 19431197
• Product Code: PEA
• UDI-Device Identifier: 04961333232598
• UDI-Public: 04961333232598
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 07/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1