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

Model Number	EPK-I8020C
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the endoscope image was lost multiple times during the procedure.Video processor video output was not lost.This event occurred at the time of during 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
01-feb-2024 with the following questions.-the issue occurred while being used on a patient.The examinations were completed with the same endoscopes when the issue occurred.The issue occurred with two different patients.-the procedure went for slightly longer due to the image loss issue.-no injury, non-additional medical intervention taken.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.9610877-2024-00005_epk-i8020c_a0023z0336_lost image patient 1 9610877-2024-00009_epk-i8020c a0023z0336_lost image patient 2.
Additional Manufacturer Narrative
Correction information: b4: date of this report.G6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: d4: primary unique device identifier (udi)#.H4: device manufacture date.Evaluation summary: based on the investigation, a potential root cause of this failure is terminals are not connected correctly due to connector section floating.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 06-jun-2023 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 on 07-jun-2023.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• 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: 18692254
• Report Number: 9610877-2024-00009
• Device Sequence Number: 7127159
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: 04961333247929
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/22/2024

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: 01/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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