MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO COLONOSCOPE 3.8C 11.6T 1700L FWJ

Model Number	EC-3490LK
Medical Device Problem Codes	Break (1069); No Display/Image (1183)
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.
Event or Problem Description
No video image.This event occurred at the time of unknown.There was no report of patient harm.
Additional Manufacturer Narrative
B4: date of this report.D4: unique identifier (udi).E1:1.Name and address.G2: report source.G6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacture.H6: coding changed based on the investigation result.H4: device manufacture date.Evaluation summary: we checked the returned unit and confirmed that the ccd module as video image failure(black out).Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the operation channel kink, the angle wire stretched, the angle wire grinding, the insertion flexible tube (ift) crushed, the light guide cable buckled, and the electrical connector pin bend.The device has been repaired.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 22-feb-2012 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 23-feb-2012.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: VIDEO COLONOSCOPE 3.8C 11.6T 1700L 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 ; 8004315880
• MDR Report Key: 13502453
• Report Number: 9610877-2022-00281
• Device Sequence Number: 5101003
• Product Code: FDF
• UDI-Device Identifier: 04961333232260
• UDI-Public: 04961333232260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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-3490LK
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2012
• 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