MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BRONCHOSCOPE; UNKNOWN

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Death  

Event Description

The customer originally reported: we have had several lung transplant patients with mycobacterium immunogenum identified in bronchoalveolar lavage specimen (bal).After review, it was found that all of these patients had bronchoscopy with disposable and reusable olympus scopes.Our physician reviewed the lab processes.The bal results were all from direct specimens with no dilution.There was no gap identified in the lab process.The physician observed a bronchoscopy and identified no gaps in the procedure.No water/ice was introduced into the patient during the procedure.The facility randomly chose one bronchoscope to culture, and it tested positive for mycobacterium immunogenum.The medivators were cultured (results not provided).The customer consulted with state health office and the cdc requesting recommendations, and they advised to reach out to the manufacturer.The customer stated plans to culture the rest of the bronchoscopes in their fleet (n-52) over the next month.The facility¿s internal lab is unable to perform environmental cultures on solid surfaces such as sinks and prep tables due to the needed swabs and lab processes required.Additional information was requested from the customer and the customer provided a table of seven patients involved, as well as culture results for the one bronchoscope that was randomly tested and found to be positive for mycobacterium immunogenum.Case with patient identifier (b)(6) reports patient 1 of 7 with mycobacterium immunogenum identified in bal.Case with patient identifier (b)(6): 8th related complaint reported by customer (positive scope culture-no patient involvement reported).Case with patient identifier (b)(6) reports patient 7 of 7 with mycobacterium immunogenum identified in bal.Case with patient identifier (b)(6) reports patient 6 of 7 with mycobacterium immunogenum identified in bal.Case with patient identifier (b)(6) reports patient 5 of 7 with mycobacterium immunogenum identified in bal (this report).Case with patient identifier (b)(6) reports patient 4 of 7 with mycobacterium immunogenum identified in bal.Case with patient identifier (b)(6) reports patient 3 of 7 with mycobacterium immunogenum identified in bal.Case with patient identifier (b)(6) reports patient 2 of 7 with mycobacterium immunogenum identified in bal.After a bronchoscopy for unstated indication, the patient¿s bal specimen was positive for mycobacterium immunogenum.The patient was not treated for mycobacterium immunogenum positive bal.The patient's current condition is reported to be ¿deceased¿ (cause of death not provided).The model and serial number of the bronchoscope used in this case could not be provided, it was not documented.Additional details have been requested.At this time, no further information has been provided.

• Brand Name: BRONCHOSCOPE
• Type of Device: UNKNOWN
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13659571
• MDR Text Key: 286514808
• Report Number: 2951238-2022-00340
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2022,03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 22 KG