MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC RADIAL PROBE; ULTRASOUND PROBE

Model Number	PB2020-M
Medical Device Problem Codes	Crack (1135); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fujifilm performed an initial investigation on the probe and noted that liquid paraffin may have leaked from the distal tip of the probe.The investigation is ongoing.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2021, fujifilm corporation was informed of an issue with its pb2020-m miniprobe.During a robotic bronchoscopy procedure, the probe appeared to be difficult to advance at times.However, the procedure was completed without requiring excessive force.The patient was unharmed, and no adverse event occurred.The probe had not been used prior to this procedure.Following the procedure, the miniprobe was inspected; blood was found inside the probe and a crack in the distal tip was observed.
Additional Manufacturer Narrative
Based on the results of the investigation, fujifilm believes that the pb2020-m tip was damaged from contact with an edged surface.Fujifilm suspects the edged surface to be located either inside the forceps channel or on the forceps channel outlet of the robotic bronchoscope system, but a clear cause cannot be established.The pb2020-m operation manual contains the following cautions: slowly insert this product into an endoscope.Inserting it quickly or forcefully may cause damage to tissues in the body cavity, bleeding or perforation.(1.3.3).If it is difficult to insert this product through the instrument channel, do not push in forcibly.Doing so may damage this product or an endoscope.(4.1).If any additional relevant information becomes available, a supplemental report will be submitted.

• Brand Name: FUJIFILM ULTRASONIC RADIAL PROBE
• Common Device Name: ULTRASOUND PROBE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 11598728
• Report Number: 3001722928-2021-00005
• Device Sequence Number: 19734489
• Product Code: ODG
• UDI-Device Identifier: 04547410343052
• UDI-Public: (01)04547410343052
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K171207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: PB2020-M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1