MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE INSPIRA; 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	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pentax medical america responded via email on october 29, 2024 with the information that it made a good faith effort to gather additional information regarding this incident and the patient was under anesthesia when the issue was discovered.It was not an emergency procedure.The procedure was aborted at that time, although i'm unsure if they used a different endoscope system to perform it at a later time.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.9610877-2024-00160_epk-i8020c_(b)(6)_ would not recognize scopes.Epk-i8020c_(b)(6)_ would not recognize scopes.
Event or Problem Description
Per the initial report, customer went to use their i10 scopes on a travel cart for a bedside icu case.However, the video processor in question wouldn't recognize any of their i10 scopes.Tried 3 different scopes in total, none of which worked.Description of any actions taken: procedure was aborted.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
Correction information: b4: date of this report.G6: follow-up #: 1.H2: if follow-up, what type? h3: device evaluated by manufacture.H6: adverse event problem.H11: additional manufacturer narrative.Additional information: d4: primary unique device identifier (udi).H4: device manufacture date.Revision summary: pentax medical america responded via email on october 29, 2024, with the information that it made a good faith effort to gather additional information regarding this incident and the patient was under anesthesia when the issue was discovered.It was not an emergency procedure.The procedure was aborted at that time, although pentax medical america's on-site staff was unsure if a different endoscope system was used to perform it at a later time.Reasons for revision: the term 'i' felt inappropriate in the initial report, so it was revised to 'pentax medical america's on-site staff.' this change was made to clarify that the information was provided by a representative of the organization, not an individual.Evaluation summary: event that occured is the video processor in question wouldn't recognize any of their i10 scopes.Based on the reported details and repair record, it was determined that the connection failure occurred due to a looseness of the scope connector mechanical unit parts.It is potential that the cause of the failure was looseness due to repeated scope attach/detattach, but it was not identified.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 22-sep-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 09-oct-2023.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.9610877-2024-00160_epk-i8020c_(b)(6)_ would not recognize scopes_fu1.9610877-2024-00161_epk-i8020c_(b)(6)_ would not recognize scopes_fu1.

• 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: 20584643
• Report Number: 9610877-2024-00161
• Device Sequence Number: 8650495
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: (01)04961333247929(11)230922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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