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

Model Number	UM-S20-20R-3
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8010047-2020-05391
• Device Sequence Number: 3447380
• Product Code: ITX
• UDI-Device Identifier: 04953170078705
• UDI-Public: 04953170078705
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 01/16/2021
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1