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

Model Number	EC-3490LK
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
F10 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 4582 no clinical signs, symptoms or conditions.Health effect impact code: 2199 no health consequences or impact.Medical device problem code: 2170 suction problem.Component code: 4755 part/component/sub-assembly term not applicable.Fda forwarded medsun mandatory and voluntary report form 2633020000-2023-8003 to pentax medical via email on (b)(6) 2023.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Patient involved - no known adverse event.Per the initial report, an event occurred during a patient's colonoscopy procedure.The device malfunctioned and there was a concern for potential perforation due to the malfunction.In regard to this event, and others, the endoscope suctions the luminal contents without the suction button being pressed.Once this starts, it tends to get worse.In some cases, changing the valve to a non-disposable valve improved/resolved the issue.This leads to poor and non-sustained insufflation of the intestinal lumen, resulting in poor visualization of the lumen.This impacts:(1) the ability to identify abnormalities, therefore the possibility of missing pathology; (2) recognizing landmarks necessary to complete the procedure, and (3) prolonging the procedure or rendering it harder to complete.Eventually, and in the more serious events, suction overcame insufflation resulting in suction into the mucosa.This leads to extreme difficulty completing the procedure, mucosal injury through creation of 'suction polyps', and mucosal trauma as was documented.The inability to maintain luminal insufflation also gives rise to the suspicion of perforation, which then has ramifications including non-completed procedure.This event occurred at the time of during use.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
Correction information date of this report.Refer to h10 follow up #01 updated dates updated dates additional information age of device evaluation summary based on the content of investigated data, it was determined that the potential cause/root cause of the failure was due to failure of another company's disposable suction valve.There is no disposable suction valve in hoya's product lineup.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 04-dec-2008 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 05-dec-2008.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; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 17058165
• Report Number: 2518897-2023-00030
• Device Sequence Number: 6771568
• Product Code: FDF
• UDI-Device Identifier: 04961333142804
• UDI-Public: 04961333142804
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023
• Report Date (Section F): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EC-3490LK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2023
• Device Age: 180 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 18 KG
• Date Report Sent to FDA: 08/21/2023