MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; ULTRASOUND VIDEO BRONCHO SCOPE

Model Number	EB-1970UK
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pentax medical canada performed good faith effort to gather additional information regarding this event.The patient visited another medical institution, but further details were not available.There are no complaints of the following symptoms at this time.-any type of intervention done to the patient as a result of the event, the patient outcome, and concomitant medical products and therapy dates (if applicable)? no.-patient has medical history including pre-existing medical condition? no.-was the procedure for treatment or diagnostic purposes? diagnostic.-was the product in question used to complete the procedure? yes.-was the patient recalled for further screening? no.-if no, will the patient be recalled for further screening? no.-what is the current status of the patient? no harm to the patient.-any additional information: only thing is that the angle at which needle was coming out.Evaluation summary: based on the investigation results data, it was determined that the segment which drives angulation had disconnected from the insertion tube.The screw mechanism segment was repaired and, the issue was corrected.Service evaluation concluded wear and tear as the cause.The endoscope was used on a patient and was found to cause no harm to the patient.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 23-jan-2023 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 23-jan-2023.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
Event or Problem Description
Customer reported that the ultrasound crystals appear to be off to one side and ebus needles coming out the distal tip at an odd angle.No injury or death involved.Only the potential to due to the unpredictability of the angle of the needle coming out the distal tip.This event occurred at the time of during use.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.

• Brand Name: PENTAX
• Common Device Name: ULTRASOUND VIDEO BRONCHO SCOPE
• 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: 18717842
• Report Number: 9610877-2024-00010
• Device Sequence Number: 12821702
• Product Code: EOQ
• UDI-Device Identifier: 04961333148226
• UDI-Public: 04961333148226
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131946
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB-1970UK
• 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: 02/05/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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
• Patient Sex: Unknown