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

Model Number	OE-A63
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event problem and evaluation codes: (b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint that occurred in the operating room during use in the united states.The reported complaint that, "the dec [distal end cap] disposable cap became dislodged during procedure.The cap was located and found within the patients mouth," involving pentax medical sterile distal end cap accessory, model oe-a63, lot number 0011089.The sterile single use distal cap was used with pentax medical video duodenoscope model ed34-i10t2, unknown serial number.The procedure required medical intervention to remove the dislodged distal end cap from the patient.Based on a follow up with the pentax sales rep on 21-aug-2020, via phone, he informed me that the event date was several months prior to his 13-aug-2020 awareness.The user facility does not know the specific case, the endoscope serial number used in the case, event date, patient and case details, so they are all unknown and will not be available.He re-stated the event saying that when the user facility noticed the missing dec, they began their search for the missing dec, found it in the patient's mouth, and the dec was removed, and discarded.That lot of decs was put aside by the facility, and will be returned to pentax for evaluation.No injury to the patient was noted.We confirmed that the user facility was trained on the installation of the dec, and have been performing 2 or 3 cases per day since installation.Since the dec dislodging event they have been having two individuals present when attaching the dec to the endoscope to make sure the cap was installed correctly, and the click was observed.On 21-aug-2020, a device history record(dhr) review for model oe-a63, lot number 0011089 was performed under ivai-20-080049.The dhr review confirmed the endoscope was manufactured on 01-aug-2019 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 for 09-aug-2019.
Event or Problem Description
Refer to h10.
Additional Manufacturer Narrative
H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect impact code: 2199 no health consequences or impact.Component code: 424 cap.Type of investigation: 4114 device not returned.Investigation findings: 3221 no findings available.Investigation conclusions: 4315 cause not established.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: STERILE DISTAL END CAP
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10525355
• Report Number: 9610877-2020-00148
• Device Sequence Number: 16190728
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0011089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown