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

Model Number PVK-1070Z

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 296951579
• Report Number: 9610877-2022-00361
• Device Sequence Number: 1
• Product Code: FEA
• UDI-Device Identifier: 04961333240364
• UDI-Public: 04961333240364
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: PVK-1070Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 02/07/2022; 02/07/2022
• Supplement Dates FDA Received: 12/02/2022; 12/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1