MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number	EG-1690K
Medical Device Problem Codes	Suction Problem (2170); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient involved - no known adverse event.Per the initial report, endoscope used during procedure failed to blow air and allow insufflation of the upper gi tract precluding completion of the procedure safely.The procedure was therefore suspended, and followed by multiple troubleshooting steps that failed until the scope was changed (larger scope available on site).Therefore, team had to request equivalent 17 series scope, which, after inherent delay, was used to complete the endoscopy uneventfully.Patient had increased duration of procedure over routine 5 mins.There are several events, and this issue has been experienced by several physicians.In all instances, the procedure (usually but not exclusively a colonoscopy) starts uneventfully.During the procedure, more likely if prolonged / poor cleanout, 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: the ability to identify abnormalities, therefore the possibility of missing pathology, recognizing landmarks necessary to complete the procedure, and 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
Fda forwarded medsun mandatory and voluntary report form (b)(4)to pentax medical via email on 24-may-2023.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Mdr 9610877-2023-00158 was being submitted to the fda for model eg-1690k, serial number (b)(6).Mdr 9610877-2023-00159 was being submitted to the fda for model eg-1690k, serial number (b)(6).
Additional Manufacturer Narrative
Correction information b4: date of this report 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 based on the content of investigated data, it was determined that the potential cause/root cause of 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 (b)(6) 2018 under normal conditions.The endoscope was reworked forout of reinforced pipe range including readjustment and passed required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for (b)(6) 2018.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
Additional Manufacturer Narrative
Correction information b4: date of this report g1:contact office g6: follow up #2 h2:if follow-up, what type? there were typos in some of the investigation results, which have been corrected.Based on the content of the examined data, the potential causes/root causes of the failure are: disposable air/water valves from other companies.Hoya's lineup does not include disposable air/water valves.A device history record (dhr) review was performed by the manufacturer.Dhr review confirmed that this endoscope was manufactured under normal conditions at pentax medical miyagi on (b)(6) 2018.The endoscope has been reworked including reconditioning outside the reinforced pipe area and passed the necessary inspections, and was released accordingly.It was also confirmed that there were no concessions and that the shipping authorization date and actual shipping date was (b)(6) 2018.Pentax medical considers this his medwatch report closed as we have not received any additional information regarding this event.

• Brand Name: PENTAX
• Common Device Name: VIDEO UPPER G.I.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 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 17076221
• Report Number: 9610877-2023-00158
• Device Sequence Number: 6273576
• Product Code: FDS
• UDI-Device Identifier: 04961333146192
• UDI-Public: 04961333146192
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131902
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2024

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: EG-1690K
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 05/24/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/20/2023; 02/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 MO
• Patient Sex: Male
• Patient Weight: 7 KG