MAUDE Adverse Event Report: OLYMPUS SURGICAL TECHNOLOGIES AMERICA SINGLE USE SUCTION VALVE (STERILE); BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number MAJ-209

Device Problems Unintended Ejection (1234); Detachment of Device or Device Component (2907)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/22/2019

Event Type  malfunction  

Event Description

During a bronchoscopy with ebus, the suction valve and tubing came off the ebus scope and splattered the room, ceiling and 4 staff members with blood.Staff did not have a blood and body fluid exposure to non intact skin or orifices.Physician feels that either the suction valve is not secured tightly or that the weight of the suction tubing is pulling it off.Physician states he normally checks the suction valve before starting the procedure and secures it.However, with this case he did not check to make sure the suction valve was tight.Manufacturer response for suction valve, single use suction valve (per site reporter): olympus medical contacted at (b)(4).Product returned to (b)(4) on 5/1/2019 via (b)(4).

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS SURGICAL TECHNOLOGIES AMERICA; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8594970
• MDR Text Key: 144564764
• Report Number: 8594970
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019,04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-209
• Device Catalogue Number: MAJ-209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 95