MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc.Omsc checked the subject device and found the reported phenomena (the body fluid invasion into inside the distal end sheath and the hole on the insertion section sheath).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc surmised that the hole on the insertion section sheath was attributed to the insertion section sheath being pinched by forceps and so on.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during the preparation for an echo bronchoscopy with the subject device, it was found that the ultrasound transducer of the distal end of the subject device had a roughness.The user facility replaced the subject device to another similar device to complete the procedure without any problems.Omsc found that there was an invasion of body fluid into inside the distal end sheath of the subject device, and that there was a hole on the insertion section sheath during the incoming inspection of the subject device.There was no report of patient injury associated with this event.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• 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: 12369289
• MDR Text Key: 268247049
• Report Number: 8010047-2021-10768
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1