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

Model Number UM-S20-17S

Device Problem Material Separation (1562)

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

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This report has been reported by the importer on mdr# 2951238-2021-00411.

Event Description

It is reported by the customer, an unspecified procedure was performed using an ultrasonic probe.The procedure went great.Once the probe was removed from the patient it was taken to the reprocessing room, where it was noticed that the radial transducer (tip) was missing from the probe.The probe is stretched about 12 inches longer than their new one, and is much thinner.The sheath that the transducer sits in is not broken.An x-ray was performed on the patient and the transducer was not seen inside the patient.The customer confirmed there was no harm to the patient.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in d8, h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The investigation is based on information provided by the customer.The device was not returned to olympus for evaluation, therefore, the user's complaint of missing ultrasound probe and stretched sheath could not be confirmed.The definitive cause of the user's experience could not be determined.

• 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: 12503527
• MDR Text Key: 272574107
• Report Number: 8010047-2021-12028
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Patient Outcome(s): Required Intervention