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

Model Number UM-S20-17S

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, service found oil leakage on the insertion tube due to breakage of the tube.The reported event (unclear ultrasound image) was also confirmed.The image was unclear due to buckling, twisting, and stretching of the insertion tube.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported that, during preparation for an unspecified diagnostic procedure, the ultrasound image was not clear from the ultrasound probe.The procedure was completed with a similar device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found there was oil leakage on the insertion tube.This report is being submitted for the malfunction found during evaluation (leakage on the insertion tube).There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the following likely caused the event: (1) tip of the sheath had a hole and ultrasound medium may have leaked from it but the cause of the hole could not be identified.(2) tip of the sheath had a hole and air may have entered from it and disabled the communication and the phenomenon resulted.However, the cause of the hole could not be identified and a definitive root cause could not be determined.The following is included in the instructions for use (ifu) and may have helped prevent the event: "freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasonic waves are emitted into the patient." "never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it." "do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation." olympus will continue to monitor field performance for this device.

• 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: 14518278
• MDR Text Key: 300588435
• Report Number: 8010047-2022-08982
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1