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

Model Number	UM-S20-17S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint was confirmed as the probe tip and its cover were found detached.Since the device is not serviced by olympus it was returned to the customer unrepaired.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.Confirmed that there was no variation.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: it was speculated that some external force was applied to the tip sheath, which resulted in the breakage of the tip sheath.Inspection results of the actual product indicate that the ultrasonic probe is damaged.From the above, it can be inferred that similar external forces were applied to the apical sheath.It is assumed that the external force applied when the stopper was used resulted in a complete rupture.
Event or Problem Description
The service center was informed that a component detached from the device, while attempting to place the stopper on.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the lm investigation and the device evaluation.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The legal manufacturer provided the following possible causes for the reported event are presumed as follows: it was speculated that some external force was applied to the tip sheath, which resulted in the breakage of the tip sheath.Pathogenesis: ·inspection results of the actual product indicate that the ultrasonic probe is damaged.·from the above, it can be inferred that similar external forces were applied to the apical sheath.·we believe that the tip sheath was broken during the above occurrence.·it is assumed that the external force applied when the stopper was used resulted in a complete rupture.Chapter 3 preparation and inspection ultrasonic probe um-bs20-26r 3.5 inspection of the endoscopic system do not place the ultrasonic probe in unclean environment.This could result in injury and pose an infection control risk.¿ to prevent damage to the ultrasound center and/or the probe driving unit, make sure that the ultrasound center is turned off before connecting or disconnecting the ultrasonic probe to the probe driving unit.¿ never disconnect the ultrasonic probe from the probe driving unit when using real-time mode (i.E., while the ultrasonic transducer is rotating).This could result in damage to the ultrasonic probe and/or probe driving unit.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.Confirmed that there was no variation.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11642239
• Report Number: 8010047-2021-04760
• Device Sequence Number: 19596080
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K982323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1