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

Model Number	EPK-I8020C
Medical Device Problem Codes	Poor Quality Image (1408); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As per customer email: i would like to escalate the ongoing issue we are experiencing with the screen going dark and red.This occurred again during dr.(b)(6) session on (b)(6) 2024 endo 1 pm list.The team used the following scopes: gastroscope - a0038a0455 (eg29-i20c), gastroscope - q00z7aa006 (eg34-i10).Unfortunately, both scopes experienced the same issue, where the screen went dark and red.We contacted you during the procedure and were advised to use another scope, but the problem persisted.They are using a 3rd scope now.Additional product information: eg34-i10: pentax medical video upper g.I.Scope eg34-i10 a3.Eg29-i20c: pentax medical video upper gi scope eg29-i20c a1.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
Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
B5: the content in the initial report was insufficient and unclear, so it has been revised as follows.On 09-dec-2024 pentax medical became aware of event involving a model epk-i8020c, serial number (b)(6) video processor in australia within the apac region.A user reported an issue where endoscopic images turned dark and red during a procedure.The facility used the following gastroscopes: - a0038a0455 (eg29-i20c), - q00z7aa006 (eg34-i10).Both scopes experienced the same issue, prompting the user to contact a pentax medical representative.They were advised to use another endoscope, but the problem persisted, requiring a third scope.While there was no physical harm to the patient, poor visibility made proper observation difficult.This resulted in the need for multiple scopes, extending both the procedure and sedation time beyond usual.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
Correction information b4: date of this report.B5: describe event or problem.D8: was this device ever serviced by a third party? g6: follow-up #: 1.H2: if follow-up, what type? h3: device evaluated by manufacture.H6: adverse event problem.Additional information d4: primary unique device identifier (udi) h4: device manufacture date h11: evaluation summary.Evaluation summary event that occurred is the screen going dark and red.Based on the investigation, a potential root cause of this failure is the adhesion of mucus or residue got on the cover glass for fibre bundles of endoscope.The adhesion of mucus or residue dried and solidified due to the illumination light, causing the colour of the illumination light to change.A definitive root cause of the reported issue could not be identified.Ifu mentioned that the user shall prepare an available processor during procedure and check the device status before using.If any abnormal found, please contact pentax employee.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 04-apr-2024.At in-process inspection, rework was performed due to ada assembly separation detected, and insw improper installation of mechanical parts, and it passed all required inspections and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed on 25-apr-2024.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: 20936817
• Report Number: 9610877-2024-00182
• Device Sequence Number: 8323658
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: (01)04961333247929(11)240406
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• 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