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

Model Number UM-S20-20R-3

Device Problem Contamination (1120)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The device was received without its original packaging and placed in a biohazard bag.A visual and microscopic inspection of the device revealed three deep scrape marks on the tube sheath at the distal section area.The customer¿s complaint was confirmed as blood was noted to be seeping inside the distal section of the device.Due to the device being contaminated with blood, it was determined that it was no longer safe for use and no functional testing could be performed.The instruction for use states, ¿do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the probe passes smoothly.You may have to withdraw the probe and lubricate the distal end with a thin coat of medical-grade water-soluble lubricant.Forcing the ultrasonic probe could damage the ultrasonic probe and/or endoscope.Never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it.¿.

Event Description

The service center was informed that blood was discovered approximately 1.5 inch from the tip inside the casing of the probe.The customer reported that the blood was discovered after the procedure.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10381981
• MDR Text Key: 202205859
• Report Number: 8010047-2020-05391
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170078705
• UDI-Public: 04953170078705
• Combination Product (y/n): N
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-20R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1