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

Model Number UM-S20-17S

Device Problem Stretched (1601)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the service center for evaluation.The reported issue was confirmed; the tip of the probe was damaged with its protective cover detached.The device is non-serviceable and was returned to the customer.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The service center was informed by the central sterile processing supervisor at the user facility that the ultrasonic probe's "protective sheath stretched with stopper removal" during a procedure.No patient injury or harm was reported to olympus.The device was returned for service.

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.It has been less than 1 year, since the subject device was manufactured.Based on the results of the investigation, it is likely, that the tip sheath was stretched and broken.Resulting in dislodgement, due to excessive external forces applied to the tip sheath when attempting to remove the stopper.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "instructions single use guide sheath kit k-401, k-402 9 operation, 9.2 inspection.Inspection of operation: attachment of the us stopper caution.¿ review the instruction manual of the ultrasonic probe for the inspection and operation of the ultrasonic probe.¿ when attaching the us stopper to the ultrasonic probe, avoid contact with the insertion portion of the ultrasonic probe with your bare hands.Any grease on the insertion portion may compromise the functions of the us stopper.¿ when attaching the us stopper to the ultrasonic probe, do not force the ultrasonic probe.This may cause damage to the instrument and/or the ultrasonic probe.¿ when moving the us stopper on the insertion portion of the ultrasonic probe, do not grasp it with an excessive force, so as not to close the slit.If the us stopper is moved while the slit is closed, the ultrasonic probe may be damaged.When you use the guide sheath in combination with the ultrasonic probe, attach it as instructed below".Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information regarding the event.

Event Description

The operations manager kelley barley further reported the reported event occurred at the beginning of a bronchoscopy procedure.No device fragment fell inside the patient as the probe broke before it was ever used.The procedure could not be completed/ there was no delay and no harm to the patient.

• 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: 12849897
• MDR Text Key: 281077406
• Report Number: 8010047-2021-14863
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170241000
• UDI-Public: 04953170241000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2021
• 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: 11/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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