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

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

The probe unit was returned to the service center for evaluation.The probe unit was received with no accessories.A section of the probe cover came off and internal oil leaked out.Due to the returned condition no testing could be performed.Olympus does not provide service repairs for this product.The probe unit was returned to the customer unrepaired.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during a diagnostic bronchoscopy, the probe was inserted into the scope and completed the first pass without issue.The doctor reported that the probe was drawn the from the scope and reinserted, when it snapped and the grey sheath came apart.The piece that snapped did not fall into the patient and it was retrieved from the scope using forceps.The procedure was continued without this piece of equipment.No other devices were replaced during the procedure.The intended procedure was completed without any delay.There was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.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: this phenomenon is assumed to have been damaged and dropped because external force was applied to the distal end sheath due to handling.The legal manufacturer assumes that external forces occur in the following ways.(1) with the probe powered, he pushed it vigorously from the endoscope.(2) the endoscope was bent and pushed vigorously from the endoscope.(3) or both of (1) and (2) above in addition, we have confirmed that this phenomenon was not caused by the product or the manufacture, and that there were no problems with the safety.The legal manufacture confirmed of the contents of the instruction manual> ultrasonic probe um-s20-17s chapter 4 operation 4.1 insertion insertion of the ultrasonic probe through an endoscope ¿ do not advance or extend the probe abruptly from the endoscope's distal end.This could result in injury.4.3 withdrawal ¿ withdrawing from the endoscope do not withdraw the ultrasonic probe from the endoscope quickly.Blood, mucous, or other patient debris could spray, posing an infection-control risk.¿ when withdrawing the ultrasonic probe, always set the endoscopic ultrasound system to the freeze mode.Withdrawing when the ultrasonic probe is rotating may damage the probe.¿ when using a gastrointestinal endoscope with a forceps elevator, always lower the forceps elevator before withdrawing the ultrasonic probe.Withdrawing the ultrasonic probe with the forceps elevator raised may damage the ultrasonic probe. as the actual product is not sent to the shirakawa plant, the actual product cannot be confirmed.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.

• 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
• MDR Report Key: 11752052
• MDR Text Key: 248195485
• Report Number: 8010047-2021-05672
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1