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

Model Number UM-S20-17S

Device Problems Break (1069); Material Separation (1562)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Inspection found a section of the probe cover came off and the internal oil was observed to have leaked out.Due to the condition of the device, testing cannot be performed.This report will be supplemented accordingly following investigations.

Event Description

A report of the probe breaking during an ilogic electromagnetic navigation bronchoscopy (enb) procedure was reported.The user, placed the ultrasound probe down the ilogic catheter without incident, however upon removing the probe from the catheter the outer sheath separated from the probe.The user was able to successfully remove the piece that separated, reporter stated that nothing fell into the patient.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.

Event Description

Additional information was obtained from the customer on 22april2021.The failure occurred at the beginning of a diagnostic procedure.There was no delay in care.The physician was unable to used the radial probe for position verification for the remainder of the procedure.The device was inspected prior to use and was found to be good condition.There were no other devices replaced during the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it is presumed that external force may have broken the sheath.As stated on the ifu (instruction for use) the user manual states: do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe.Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts.Olympus will continue to monitor complaints for this device.

• 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: 11700915
• MDR Text Key: 246487788
• Report Number: 8010047-2021-05194
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 04/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COVIDIEN EDGE ENDOBRONCHIAL 180 CATHETER.; IOLOGIC CATHETER.; OLYMPUS BRONCHOSCOPE.; SIZE 8.5 ENDOTRACHEAL TUBE.; IOLOGIC CATHETER
• Patient Age: 51 YR
• Patient Weight: 68