MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS

Model Number	FB-15RBS
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	10/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pentax medical was made aware of an event on 20-nov-2023 that occurred in china within the apac region in the operating room during use.On 22-oct-2023, during a fiberoptic bronchoscopy with sputum aspiration, the endoscope entered into the patient's airway via.The trachea cannula, and when the endoscope needed to have the lens rotated, the user found that the angulation control knob could not be pressed up and down, resulting in the bending part of distal end becoming stuck in the trachea cannula.The endoscope could not be withdrawn successfully which result in the patient's airway being restricted, and the patient was in respiratory distress with an obstructed ventilation tube.The balloon was immediately deflated and the tracheal tube was removed [along with the endoscope], and only the tracheal tube was reinserted and connected to the ventilator to assist breathing.After that, the patient's breathing was stable and ventilation was restored, with oxygen saturation returning to normal.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: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1699 airway obstruction health effect impact code: 4619 temporary impairment, 4604 delay to treatment/ therapy medical device problem code: 1384 mechanical problem, 4012 physical resistance/sticking component code: 3111 steering wire, 4727 cable, mechanical/structural 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 this device is not distributed in us so that 510k is blank.______________ pentax medical apac performed good faith efforts to gather additional information regarding this event and provided an email response on 11-dec-2023 for the following questions.Q1.According to the narrative, the malfunction of the angulation control knob resulted in the bending part of distal end stuck in trachea cannula.Did the site notice any abnormality in the movement of the endoscope in addition to that? a: no other abnormality was found during use.Q2.Check the inside diameter of the tracheal tube they used during the procedure.A: 7.5-8mm q3.Has the patient still been hospitalized or already discharged from the hospital? if yes, is the prolongation of hospitalization due to this event? or is it due to the patient's medical history (not related to this event)? a:the patient had been discharged.If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1699 airway obstruction.Health effect impact code: 4619 temporary impairment, 4604 delay to treatment/ therapy.Medical device problem code: 1384 mechanical problem, 4012 physical resistance/sticking.Component code: 3111 steering wire, 4727 cable, mechanical/structural.Type of investigation: 10 testing of actual/suspected device, 3331 analysis of production records.Investigation findings: 140 wear problem.Investigation conclusions:4307 cause traced to component failure.Evaluation summary: the pentax medical engineer checked with hospital staff.The device was used for examination.No harm was caused to the patient.The examination was completed with other device.The patient had discharged.Pentax medical investigated the situation with the hospital.As the chief physician was busy with work, he did not remember the specific situation, and the repair was completed by a thirdparty organization, so pentax medical could not know the specific situation.The loss of the angle was probably due to a broken angle wire, but it was also likely due to aging and wear of accessories, as the endoscope had reached the end of its useful life.The device was repaired by the third party and returned to the hospital.Pentax medical reminded the hospital that they should pay attention to pre-use check, and check the device regularly.Since the device was out of service life, the hospital was urged to purchase a new one and stop using the complaint device.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 19-apr-2017 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 19-apr-2017.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS
• 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: 18315413
• Report Number: 9610877-2023-00275
• Device Sequence Number: 17815022
• Product Code: EOQ
• UDI-Device Identifier: 04961333070497
• UDI-Public: 04961333070497
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: FB-15RBS
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2017
• 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 Age: 84 YR
• Patient Sex: Female