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

Model Number FB-15RBS

Device Problems Mechanical Problem (1384); Physical Resistance/Sticking (4012)

Patient Problem Airway Obstruction (1699)

Event Date 10/22/2023

Event Type  Injury  

Event 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and down, resulting in the bending part of distal end becoming stuck in the trachea cannula.The endoscope could not be withdrawn successfully which result in the patient's airway being restricted, and the patient was in respiratory distress with an obstructed ventilation tube.The balloon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.

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.

• Brand Name: PENTAX
• Type of Device: 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
• MDR Text Key: 330331107
• Report Number: 9610877-2023-00275
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04961333070497
• UDI-Public: 04961333070497
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB-15RBS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female