MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO COLONOSCOPE 3.8C 2.8C 13.2T FWJ

Model Number	EC-3890TLK
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Video image failure(fluid damage).
Additional Manufacturer Narrative
We checked the returned unit and confirmed that the ccd driver pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd driver pcb.In addition, we confirmed that the light guide cable fluid damage, the lg cable connector fluid damage, the insertion flexible tube (ift) coating damage, the light guide cable buckled, the lg root brace rubber cracked, the lg cable connector housing cracked, the lg cable connector corroded, the lg cable connector housing leak, the root brace rubber cut, the distal body worn out, the insertion flexible tube (ift) bump, and the distal end assy w/ccd module shadow in image; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Common Device Name: VIDEO COLONOSCOPE 3.8C 2.8C 13.2T FWJ
• 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
• MDR Report Key: 16231115
• Report Number: 9610877-2023-50609
• Device Sequence Number: 15201947
• Product Code: FDF
• UDI-Device Identifier: 04961333147700
• UDI-Public: 04961333147700
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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-3890TLK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/24/2023
• 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