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

Model Number	EPK-I8020C
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Inspira processor did not recognise the device.The customer informed us by e-mail as follows "it got even worse the other day when an endoscopy had to be carried out on a bleeding patient in the intensive care unit and the same error occurred again.The endoscopy specialist had to run back to the endoscopy department and fetch a new device.This loss of time can be life-threatening for the patient." information from the hospital: there was no incident involving the patient.A bleeding patient was to be examined.The cause of the haemorrhage is unknown.For this reason, the emergency trolley was taken to the intensive care unit.There it was determined that the device was not recognised by the processor.(before the examination) another device was fetched from the endoscopy department some distance away, which led to a time delay.Exactly this time delay can be life-threatening.The defective processor is our loaner epki-8020c b0023z0223 the series of endoscopes used is the i20c series.I do not know the software status.This event occurred at the time of before use.There was no report of patient harm.B3:not known for the exact date, we just know the year the complaint was sent in to manufacturer.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.
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)#.D9: is this device available for evaluation? h4: device manufacture date.Evaluation summary: event that occured is the processor did not recognise the device.Based on the investigation, a potential root cause of this failure is terminals are not connected correctly due to connector section floating.The review by dhr confirmed that the processor was manufactured under normal conditions on 10-aug-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 10-aug-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: 19785789
• Report Number: 9610877-2024-00063
• Device Sequence Number: 15523589
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: (01)04961333247929(11)230711
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 07/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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