MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC PROBE PB2020-M; ENDOSCOPE AND ACCESSORIES

Model Number	PB2020-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to the diagnostic procedure on (b)(6), 2022, the facility cut off a portion of the probe sheath and re-used the subject probe.A repeat bronchoscopy was performed on (b)(6), 2022 in an attempt to remove the probe piece from the patient.However, the removal procedure was unsuccessful due to the location and position of the probe piece, and its small size.The patient is reported to be in stable condition and will continue to be monitored by the physician to ensure that an adverse reaction to the foreign object does not occur.A supplemental report will be submitted pending investigation results.
Event or Problem Description
On august 11, 2022, fujifilm corporation became aware of an event involving pb2020-m.It was reported that during a diagnostic study the tip of the subject probe came apart while inside the patient.The probe piece could not be seen on the scope image and was unable to be removed, and the study could not be completed.There was no death reported with the event.
Additional Manufacturer Narrative
Fujifilm corporation determined the root cause of the reported issue to be a result of user error.The physician cut the sheath of the probe tip and used the probe multiple times prior to the incident.Per the instructions for use, users are warned not to modify the product or its components and to immediately discontinue use if any abnormalities are noticed.
Additional Manufacturer Narrative
This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• Brand Name: FUJIFILM ULTRASONIC PROBE PB2020-M
• Common Device Name: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 15292634
• Report Number: 3001722928-2022-00017
• Device Sequence Number: 7167219
• Product Code: ODG
• UDI-Device Identifier: 04547410343052
• UDI-Public: (01)04547410343052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 10/16/2022; 10/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/20/2022; 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male