MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL)

Model Number	EPK-I7010
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The time of event is not during procedure.There was no report of patient harm.Iris diaphragm failure.
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model epk-i7010-us is available in the usa with a 510k number k182004.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the iris diaphragm as defective.Based on the result, we concluded that it was caused due to the excessive shock applied on the iris diaphragm.Based on the technical report ""hr-rpt-0973(temperature rise)"" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Common Device Name: OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 19356673
• Report Number: 9610877-2024-53772
• Device Sequence Number: 17727869
• Product Code: PEA
• UDI-Device Identifier: 04961333221141
• UDI-Public: 04961333221141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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-I7010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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