MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX MEDICAL; STERILE DISTAL END CAP

Model Number	OE-A63
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
F10: continued: health effect - clinical code: 2687 foreign body in patient.Health effect - impact code: 4641 unexpected medical intervention.Medical device problem code: 2923 device dislodged or dislocated.Component code: 424 cap.Pentax medical emea is currently performing a good faith effort (gfe) to obtain additional information regarding this event; however, as of the date of this report, no response has been received.The following information has been requested from the facility and is currently pending: information on the endoscope used in conjunction with the event, including model name and serial number.Clarification as to whether the distal end cap (dec) detached and fell off, or whether the albarran lever broke and detached.If the dec is confirmed to have detached, the following information has been requested: whether the facility was provided with the latest instructions for use (ifu).Whether the person who installed the dec was a trained and experienced user or an untrained user.Whether a clicking sound was heard during dec installation and whether the dec was pulled after installation to confirm proper locking.The specific operation or maneuver that caused the dec to detach.Whether the endoscope was returned to pentax medical for inspection and whether any abnormalities were identified.If abnormalities were identified, a request for photographic documentation.If the albarran lever is confirmed to have detached, clarification has been requested regarding how it was used and how such use may have resulted in damage to the dec.Investigation is in process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
On 12-dec-2025, pentax medical became aware of an event involving a sterile distal end cap model oe-a63 lot number 0021124 in germany within the emea region.During a duodenoscopy, the albaran lever came loose and fell off inside the patient.It was removed from the patient without causing any health problems.The affected batch is available for investigation.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
Correction information: f10 continued: international medical device regulators forum (imdrf) adverse event reporting codes updated - health effect - clinical code, health effect - impact code- updated.B4: date of this report.B5.Refer to h11.F7: follow up #01.F11: updated dates.F13: updated dates.Additional information d4: expiration date and primary unique device identifier (udi).F9: age of device.H11: evaluation summary.Pentax medical emea is currently performing a good faith effort (gfe) to obtain additional information regarding this event; however, as of the date of this report, no response has been received.The following information has been requested from the facility and is currently pending.The following information has been requested from the facility and is currently pending: information on the endoscope used in conjunction with the event, including model name and serial number.Clarification as to whether the distal end cap (dec) detached and fell off, or whether the albarran lever broke and detached.If the dec is confirmed to have detached, the following information has been requested: whether the facility was provided with the latest instructions for use (ifu).Whether the person who installed the dec was a trained and experienced user or an untrained user.Whether a clicking sound was heard during dec installation and whether the dec was pulled after installation to confirm proper locking.The specific operation or maneuver that caused the dec to detach.Whether the endoscope was returned to pentax medical for inspection and whether any abnormalities were identified.If abnormalities were identified, a request for photographic documentation.If the albarran lever is confirmed to have detached, clarification has been requested regarding how it was used and how such use may have resulted in damage to the dec.Investigation is in process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Refer to h11.

• Brand Name: PENTAX MEDICAL
• Common Device Name: STERILE DISTAL END CAP
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 24003266
• Report Number: 2518897-2026-00001
• Device Sequence Number: 10239514
• Product Code: FDT
• UDI-Device Identifier: 04961333232994
• UDI-Public: (01)04961333232994(11)241209(17)261130(10)0021124
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/12/2026

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
• Device Model Number: OE-A63
• Device Lot Number: 0021124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/12/2025
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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
• Date Report Sent to FDA: 03/12/2026