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

Model Number	EG34-I10
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: continued: health effect - clinical code: 2687 foreign body in patient.Health effect - impact code: 4652 exposure to contaminated device / risk of infection medical device problem code: 2895 contamination /decontamination problem, 4048 failure to clean adequately.Component code: 4761 access port.Type of investigation: 4118 type of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusion not yet available.Pentax medical is currently conducting a good faith effort (gfe) through pai to gather additional information regarding this event.The information described below reflects the details obtained to date, and additional information is still being collected.On (b)(6) 2025, during a gastroscopy procedure, when the physician attempted to insert biopsy forceps through the working channel, a hemostatic clip was unexpectedly expelled into the patient's esophagus.The physician reported difficulty advancing the biopsy forceps at that time.The expelled clip was successfully retrieved endoscopically.After completion of the procedure, the endoscope was sent for cleaning and reprocessing in accordance with the facility's standard protocol.During manual brushing of the working channel, a second hemostatic clip was expelled from the endoscope.According to the facility, three clips had been deployed during a previous procedure, and difficulty with clip adhesion to the mucosal wall had been reported.The endoscope had undergone routine high-level disinfection and cleaning prior to the event, with the most recent reprocessing performed on 26-nov-2025.The hemostatic clip was retrieved from the patient, and no patient harm has been reported at this time.Additional patient follow-up information is pending from the facility.Pentax medical has requested inspection of the device, and further information is being collected from the facility, including details regarding reprocessing practices and accessory handling procedures.Investigation is in process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
On 27-nov-2025, pentax medical became aware of an event involving a pentax medical video gastroscope model eg34-i10 serial number (b)(6) in canada within the pai region.During an endoscopic procedure, it was reported that a hemostatic clip used for a previous patient remained in the instrument channel and dropped into the patient's body.The dropped hemostatic clip was identified as a boston scientific resolution 360 ultra clip size 2.8 mm.The dropped hemostatic clip was retrieved from the patient's body.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
H6: continued: health effect - clinical code: 2687 foreign body in patient health effect - impact code: 4652 exposures to contaminated device / risk of infection medical device problem code: 2895 contamination /decontamination problem, 4048 failure to clean adequately component code: 4761 access port type of investigation: 10 testing of actual/suspected device, 4110 trend analysis, 3331 analysis of production records investigation findings: 4228 devices incorrectly reprocessed investigation conclusions: 19 causes traced to user, 4315 causes not established.Correction information b4: date of this report - updated d9: is this device available for evaluation? -yes g1: contact office - updated g6: follow-up #: 1 h2: if follow-up, what type? - updated h3: device evaluated by manufacturer - "no" to "yes" h6: codes updated - type of investigation, investigation findings, investigation conclusions-updated.Additional information d4: primary unique device identifier (udi) h4: device manufacture date h11: evaluation summary.Evaluation summary the reported event was that a hemostatic clip was left inside the endoscope instrument channel and subsequently fell into the patient.Based on the investigation, during an endoscopic procedure, when attempting to remove a clip from the patient using the suction function, the clip became caught in the inlet t-piece.During the subsequent reprocessing process, the staff did not notice that the clip had become stuck in the channel.In the next endoscopic procedure, the user did not thoroughly inspect the instrument channel with a treatment tool during the pre-use inspection and therefore did not notice the presence of the clip remaining in the channel.During the following procedure, the clip that remained inside the channel was pushed out by the treatment tool and fell into the patient.A definitive root cause of the reported issue could not be identified.To date, no patient harm has been reported.A device history record (dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured at pentax medical miyagi on 14-jul-2023 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 01-aug-2023.Based on the trend analysis, there is no significant increase or upward trend in repair complaints related to this failure mode or hazard.Pentax medical has not received any further information for this event and therefore considers this medwatch report closed.

• Brand Name: PENTAX MEDICAL
• Common Device Name: VIDEO UPPER G.I.SCOPE
• 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: paresh patel ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 23812397
• Report Number: 9610877-2025-00218
• Device Sequence Number: 13085111
• Product Code: FDS
• UDI-Device Identifier: 04961333233991
• UDI-Public: (01)04961333233991(11)230714
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180292
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: EG34-I10
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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: Required Intervention
• Patient Sex: Unknown