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

Model Number	EC-3490LI
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review for model ec-3490li, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 12 aug 2011 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.The reported customer complaint of no video image was not confirmed through evaluation of the device.Evaluation findings were listed as: ccd driver circuit board incorrect scope parameter, play in the up/down angulation knob, passed both wet and dry leak tests, nofluid invasion observed in the control body or the pve connector.The device was cleaned and disinfected, video image calibration performed and angulatin adjustment made and the device was returned to the customer.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
A customer reported that there was dark imaging on the screen of a ec-3490li- video colonoscope.The timing and location of the observation are unknown at this time.There were no patient or user injuries, adverse events, delay, or medical intervention reported.

• Brand Name: PENTAX
• Common Device Name: VIDEO COLONO SCOPE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13023410
• Report Number: 9610877-2021-01836
• Device Sequence Number: 4769474
• Product Code: FDF
• UDI-Device Identifier: 04961333232253
• UDI-Public: 04961333232253
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: EC-3490LI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2011
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown