MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE

Model Number BF-1T180

Device Problems Biofilm coating in Device (1062); Loose or Intermittent Connection (1371)

Patient Problems Bacterial Infection (1735); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The scope was returned to the service center however the investigation is ongoing. A review of the service history of the scope indicates the scope was purchased on (b)(6) 2009 and there are four repairs in the past three years. The last repair involved a loose biopsy port. In addition, an endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that the scope's biopsy port was noted to be loose. The biopsy port was reportedly taken apart and foreign residue was present. There was no patient injury reported, however, the user facility reported the scope was linked to two cases of possible contamination. This is for 2 of 2 reports.

• Brand Name: EVIS EXERAII BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9238618
• MDR Text Key: 202877884
• Report Number: 8010047-2019-03711
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/25/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: BF-1T180
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse