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

Model Number	FB-15RBS
Medical Device Problem Codes	Break (1069); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pentax medical apac responded to a good faith effort request via email on 21-july-2023 that the damage was light source socket.Also according to the device department, the endoscope has become unglued, resulting in a fracture.The hospital only had one endoscope, the patient changed the date for examination.This device is not distributed in us so that 510k is blank.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
The battery cold light source might break at the connection with the processor due to improper force when examining the patient.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.
Additional Manufacturer Narrative
Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d4:unique identifier (udi) d8:was this device serviced by a third party? h4:device manufacture date evaluation summary the pentax engineer checked with hospital staff.The device was used for examination.The device was repaired by the third party and returned to the hospital.Pentax reminded the hospital that the daily operation and reprocessing procedure should be regulated in accordance with the ifu, which can reduce the occurrence of accidents.Based on the content of investigated data, it was determined that the potential cause/root cause of failure was that inappropriate force was applied when connecting the battery-powered light source to the scope.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on (b)(6) 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 (b)(6) 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: PORTABLE BRONCHO SCOPE
• 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 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17402085
• Report Number: 9610877-2023-00187
• Device Sequence Number: 17601597
• Product Code: EOQ
• UDI-Device Identifier: 04961333224081
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: FB-15RBS
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2017
• 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
• Patient Sex: Unknown