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

Model Number	EC-3490TLI
Medical Device Problem Codes	Poor Quality Image (1408); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The endoscope had a smudged and blocked vision on lens-stream of water that is suppose to come out of water feeding channel was weak/not able to clear debris; any visual disturbance has potential for missing pathology." "loaner scope pilot colonoscope- smudge to left side of lens during colonoscopy; potential for missed pathology" "blurry image all over lens from scope pilot colonoscope; potential to miss pathology when this happens" "smudge to lens- a line from 2-7 o clock; potential for missed pathology" "blurriness to right lower quadrant on lens; potential for missed pathology" "blurriness to lens during colonoscopy; from 7-9 o clock position.Unable to assess the rest of colon accurately; unable to assess for pathology/potential for perforation" "blurriness to lens during colonoscopy; unable to assess colon for pathology/potential for perforation of colon".This event occurred at the time of during use.There was no report of patient harm.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Correction information.B4: date of this report.D9: device available for evaluation? g6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information.H4:device manufacture date.Evaluation summary: pentax service records were reviewed.There was mention of a blurry image/image cloudy complaint.Evaluation found the distal lens was dirty/stained.Lens was replaced.The problem is intermittent and does not seem to be design related, but rather is impacted by the challenging environmental conditions in british columbia (insufficient colon prep and lipid rich contaminants) during colonoscopy.Site specific issues such as water quality are potentially a contributing factor.Improper reprocessing potentially caused image defects due to mucus adhesion during use.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 23-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 24-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 COLONO SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 18213288
• Report Number: 9610877-2023-00262
• Device Sequence Number: 20486352
• Product Code: FDF
• UDI-Device Identifier: 04961333166619
• UDI-Public: 04961333166619
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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-3490TLI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2012
• 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