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

Model Number	EPK-I5500C-US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the image freezes intermittently on 025-feb -2021: scope receptacle misaligned.The device underwent replacements for the following components: global receptacle.The technician applied alignment to the videoscope.Model epk-i5500c-us, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 13-jan-2020.The endoscope was approval by final qc on 27-jul-2021 and is pending delivery to the customer.Tthis complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.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 on 22-jan-2021 involving pentax medical video processor model epk-i5500c-us, serial number (b)(4) with the description of "takes dozens of pictures intermittently, freezes and blacks out during procedures." the unit was received by pentax medical for evaluation on 28-jan-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the "scope connector intermittent endoscope signal" and "scope connector unit storage receptacle misaligned" on 28-jan-2021.The device underwent repairs including the following components: global receptacle.Pentax medical model epk-i5500c, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 11-feb-2020.The device was repaired and approved by final qc on 28-jan-2021 and returned to the customer.

• Brand Name: PENTAX
• Common Device Name: 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: 12267899
• Report Number: 9610877-2021-00045
• Device Sequence Number: 20099070
• Product Code: PEA
• UDI-Device Identifier: 04961333232918
• UDI-Public: 04961333232918
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190805
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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-I5500C-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1