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

Model Number UM-S20-17S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the reported phenomenon.It was found that there was a hole on the sheath at the distal end and fluid was entered inside the device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined.Omsc surmised that the black scratch was that the fluid which was entered from the hole fixed inside the sheath.The hole on the sheath could occur due to the following external force applied.The device was forcibly inserted or withdrawn into/from the endoscope with the bending section bent.During probe rotation, the device was forcibly inserted or withdrawn into/from the endoscope.

Event Description

Olympus medical systems corp.(omsc) was informed by the user that during the reprocessing, the user found something like a black scratch attached to the distal end of the subject device.The user reprocessed the subject device, but it could not be removed.Other detailed information was not provided.There was no report of patient injury associated with the 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: 12311280
• MDR Text Key: 266162508
• Report Number: 8010047-2021-10130
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 08/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1