MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE INSPIRA; PENTAX MEDICAL VIDEO PROCESSOR EPK-I8020C

Model Number	EPK-I8020C
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Error in the documentation! if no new patient was selected from the worklist before a new examination, all newly taken photos are now automatically assigned to the last selected patient, even though this case was properly completed and the endoscope was removed.The display in the pacs viewer was documented in a photo.The process can be reproduced at any time.An mpps server has not yet been used.Nevertheless, the possibility of incorrect assignment should be prevented.We are currently still waiting for the conformance statement from the practice's documentation software.This should be delivered later.This event occurred at the time of before use.There was no report of patient harm.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.
Additional Manufacturer Narrative
Evaluation summary: event that occured is the no new patient was selected from the worklist before a new examination.Based on the investigation, a potential root cause of this failure is the misconfiguration of complaint device regarding dicom.It was determined that the setting to delete patient information after the examination was completed was not enabled.Because the previous patient information remained, newly captured endoscopic images were recorded as images of the previous patient.A definitive root cause of the reported issue could not be identified.Based on the trend analysis, there is no significant increase in repair complaints for this failure mode/hazard, and no increasing trend.A device history record (dhr) review was performed by the manufacturer.The review by dhr confirmed that the processor was manufactured under normal conditions on 20-may-2023.At inspection, rework was performed due to ada assembly separation detected, and it passed all required inspections and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed on 29-may-2023.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: INSPIRA
• Common Device Name: PENTAX MEDICAL VIDEO PROCESSOR EPK-I8020C
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 21015085
• Report Number: 9610877-2024-00188
• Device Sequence Number: 20549510
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: (01)04961333247929(11)230520
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K231249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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-I8020C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2023
• 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