MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES BRONCHOFIBERSCOPE

Model Number	BF-N20
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported by the customer, an unspecified time after a procedure using one of their 10 bronchoscopes, preliminary findings of fungal culture specimen collected from the patient via bronchoalveolar lavage (bal) from right middle lobe (rml) of lung shows: scant growth gram positive branching rods suggestive of aerobic actinomycete (originally reported as mold).It is unknown what treatment the patient required as a result.The patient¿s current condition is unknown.The customer states that it is not known which of their 10 bronchoscopes was used in the case, as the surgery staff did not document this information in the procedure record.For this reason, the customer is requesting all 10 bronchoscopes be evaluated to determine if any of them are potentially a contributing factor to the positive patient culture.Additional details regarding the patient and event have been requested.At this time, no further details have been provided.Case with patient identifier (b)(6) reports a bf-xp60.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-n20.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-n20.Case with patient identifier (b)(6) reports a bf-3c40.Case with patient identifier (b)(6) reports a bf-xp60.The customer further reported they had been sending their scopes to steris ims for repair.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12455467
• Report Number: 2951238-2021-00401
• Device Sequence Number: 3924793
• Product Code: EOQ
• UDI-Device Identifier: 04953170051142
• UDI-Public: 04953170051142
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2021
• Report Date (Section F): 08/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-N20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 MO