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

Model Number	EPK-I8020C
Medical Device Problem Codes	Data Problem (3196); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
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
According to it support, the images stored by inspira are not dicom-compliant; there are incorrect assignments of images to patients or storage problems.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
Evaluation summary: based on the investigation results data, it was determined that the underlying cause/root cause of the failure was that the images stored by inspira were not dicom compliant.(this is not a device malfunction.) a device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 31-may-2023 under normal conditions, passed all required inspections, and was released accordingly.The endoscope was reworked for ada - assembly disassociation and passed required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for (b)(6) 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 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 18080916
• Report Number: 9610877-2023-00248
• Device Sequence Number: 7730269
• Product Code: PEA
• UDI-Device Identifier: 04961333247929
• UDI-Public: 04961333247929
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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