MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO PROCESSOR

Model Number	EPK-3000
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: this device is classified as import for export, therefore 510k is not applicable for this specific device.Similar device being sold in the usa epk-3000-us with a 510k # k172156.(b)(4).We will continue to investigate this situation and if necessary, file a supplemental repoort.Due to memo and policy change effictive july 1, the new awareness date for this mdr will be july 1, 2021.The dt was reassessed as fda reportable on june 28, 2021.
Event or Problem Description
Pentax medical was made aware of an event which occurred in asia pacific region involving pentax video processor model epk-3000 sn: (b)(4).The event reported on 26jan2021, stated the processor was installed and the main lamp failed to light.The abnormality was observed in the procedure room before use.There was no adverse event reported with this complaint.No additional information was provided.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

• Brand Name: PENTAX
• Common Device Name: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12217227
• Report Number: 9610877-2021-00193
• Device Sequence Number: 4063151
• Product Code: PEA
• UDI-Device Identifier: 04961333240197
• UDI-Public: 04961333240197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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-3000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1