MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-S20-20R-3

Device Problem Incorrect Measurement (1383)

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Upon inspection of the um-s20-20r-3, ultrasonic probe, performed by olympus personnel, it was determined the probe tip was length was found to be out of specification.There was no patient involvement associated with the reported event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The subject device was inspected and no visible damaged was noted.The ultrasonic transducer was undamaged, and the ultrasonic medium did not leak from any holes in the tip or insertion sheaths.The probe tip was 1.5 mm longer than the specification.The reported problem was therefore confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed this issue.The dhr confirmed that the subject device was shipped in compliance with the tip clearance standards.The tip clearance may have been extended because the blade (flexible shaft) was shifted to the end of the base by a physical load (e.G.Bending).The following were identified as potential contributory factors; (a) the device may have been stored in a bent state such that the diameter was 20 cm or less, (b) during reprocessing, the inner blade may have dropped making a return to the normal state impossible, or (c) temperature or humidity effects may have induced the deformity.Ultimately, the investigation presumed that the tip clearance (the transparent sheath potion of the probe tip) may have been stretched.Although not definitive, this was established as the most likely root cause of the reported problem.Olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15220283
• MDR Text Key: 305170384
• Report Number: 3002808148-2022-00933
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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: Health Professional
• Device Model Number: UM-S20-20R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1