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

Model Number	OE-A63
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: continued: health effect - clinical code: 4580 foreign body in patient health effect - impact code: 4641 unexpected medical intervention medical device problem code: 1562 material separation component code: 424 cap type of investigation: 4118 type of investigation not yet determined investigation findings: 3233 results pending completion of investigation conclusions: 11 conclusion not yet available.Pentax medical america (pai) performed a good faith effort (gfe) to gather additional information regarding this event and received a response via email on 12-aug-2025.From the attached complaint form, it was confirmed that a duodenoscope was used in conjunction during the procedure, with the following details provided: model: ed34-i10ct2 serial number: (b)(6).No additional information regarding the procedure, patient involvement, event circumstances, or reprocessing details was provided in the form.As the root cause of the reported event could not be determined to be attributable solely to either the distal end cap or the duodenoscope, separate mdrs have been submitted for both devices.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.9610877-2025-00184_oe-(b)(6) distal end cap fell off inside patient.9610877-2025-00185_ed34-i10ct2_(b)(6) distal end cap fell off inside patient.
Event or Problem Description
On 06-aug-2025, pentax medical became aware of an event involving a pentax medical single use sterile distal end cap model oe-a63 in canada within the pai region.A single-use sterile distal end cap (dec) for a duodenoscope was attached to the distal end of the endoscope, and an inspection was conducted according to the pre-use inspection procedure.When attaching the dec, two staff members confirmed the clicking sound, and the physician visually confirmed it before inserting the endoscope into the patient.Subsequently, when the physician attempted to operate the forceps elevator, the dec detached from the distal end of the endoscope and fell into the patient's body.The physician retrieved the dec using basket forceps for a gastroscope and completed the procedure with another duodenoscope.There was no 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: 4580 foreign body in patient health effect - impact code: 4641 unexpected medical intervention medical device problem code: 1562 material separation component code: 424 cap type of investigation: 10 testing of actual/suspected device, 4110 trend analysis, 3331 analysis of production records investigation findings: 213 no device problem found investigation conclusions: 19 causes traced to user, 4315 causes not established.Correction information b4: date of this report - updated g6: follow-up #: 1 h2: if follow-up, what type? - updated h3: device evaluated by manufacturer - "no" to "yes" h6: codes updated.Additional information d4: primary unique device identifier (udi) d4: expiration date d9: is this device available for evaluation? h4: device manufacture date h11: evaluation summary.Evaluation summary: the reported event was the detachment of the cap (oe-a63).A review of production records showed no deviation or non-conformance.Based on the investigation, a potential root cause of this failure was that the cap was not securely attached, indicating that the cap may have detached and fallen into the patient's body during use of the therapeutic accessory.Examination of the detached product revealed no wear marks on the cap's locking hook, suggesting it may not have been fully inserted into its locking position.Additionally, the returned product could be attached to the scope without issue.As a supplementary event, it was reported that at this facility, a nurse experienced the cap detaching when rinsing the endoscope tip in a sterile water bottle.A definitive root cause of the reported issue could not be identified.Based on the trend analysis, there is no significant increase or upward trend in repair complaints related to this failure mode or hazard.A device history record (dhr) review was performed by the manufacturer.The review confirmed that the instrument was manufactured under normal conditions on 09-dec-2024, 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 20-dec-2024.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: 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
• 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: 22824526
• Report Number: 9610877-2025-00184
• Device Sequence Number: 4564986
• 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: CA
• PMA/510(K) Number: K192245
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: OE-A63
• Device Lot Number: 0021124
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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