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

Model Number	PVK-1070Z
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.This device is classified as import for export, therefore 510k is not applicable.
Event or Problem Description
No "knowledgement" of adverse event.Refer to expiration date as complaint notification.Customer advised: poor image quality.The time of event is unknown.This event occurred, no report of patient harm.The date of event is unknown.
Additional Manufacturer Narrative
Correction information: g6: follow up #2, h2:if follow-up, what type? h3:device evaluated by manufacture.Additional information: h4:device manufacture date.Evaluation summary: it is presumed that the event was caused by a failure in the imaging system due to long-term use (9 years) and a decrease in imaging capability.(no repair history) as for the cause of the deterioration of the imaging capability, it is thought that there are factors such as failure of the image sensor, damage to the ccd cable, breakage of the circuit pattern, etc., but we have not reached a conclusion.
Additional Manufacturer Narrative
Correction information: g6: follow up #2.H2:if follow-up, what type? model pvk-1070z is video adaptor module for fiberscope, so there is no 510k number.

• Brand Name: PENTAX
• Common Device Name: VIDEO MODULE
• 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: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13716707
• Report Number: 9610877-2022-00361
• Device Sequence Number: 17247129
• Product Code: FEA
• UDI-Device Identifier: 04961333240364
• UDI-Public: 04961333240364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2022

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: PVK-1070Z
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022; 02/07/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 12/02/2022; 12/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2013
• 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