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

Model Number UM-S20-17S

Device Problem Break (1069)

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

Event Date 06/26/2021

Event Type  malfunction  

Manufacturer Narrative

The customer informed olympus the broken tip was available for return.However, the suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus the tip of the probe or the wire at the tip broke.There is a little plastic covering at the tip.The customer did not know where the event occurred however, it involved a diagnostic procedure.No patient harm or injury reported.

Manufacturer Narrative

The supplement is being submitted to provide additional information received from the customer.The following sections have been updated: b5 d4 d9 h3 h6 after the device evaluation and updated investigation is completed, a supplement will be submitted.

Event Description

Additional information received from the customer and the olympus employee as follows: the customer reported she was sending back 2 broken probes.The olympus employee reported the facility had several broken probes.Further attempts for additional information are currently in progress.

Event Description

Additional information was received from the customer: the probe broke before the procedure.The same device was used to complete the intended procedure and no further issues occurred.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided by the customer and the legal manufacturer's investigation.The following sections were updated: b5 d8 d9 e1 e2 e3 g2 although the customer initially informed olympus the device was available for return, it has not been returned to date after multiple attempts.The dhr for this device could not be reviewed since the serial number was not provided.However, olympus only ships devices that meet all manufacturing specifications and final release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to external force applied to the tip of the probe.The event could have been prevented by following the instructions for use: chapter 4 operation - 4.1 insertion insertion of the ultrasonic probe through an endoscope do not advance or extend the probe abruptly from the endoscope ¿s distal end.This could result in injury.4.3 withdrawal withdrawing from the endoscope do not withdraw the ultrasonic probe from the endoscope quickly.Blood, mucous, or other patient debris could spray, posing an infection-control risk.¿when withdrawing the ultrasonic probe, always set the endoscopic ultrasound system to the freeze mode.Withdrawing when the ultrasonic probe is rotating may damage the probe.¿when using a gastrointestinal endoscope with a forceps elevator, always lower the forceps elevator before withdrawing the ultrasonic probe.Withdrawing the ultrasonic probe with the forceps elevator raised may damage the ultrasonic probe.

• 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: 12198009
• MDR Text Key: 263439914
• Report Number: 8010047-2021-09131
• 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: 09/15/2021

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
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 08/31/2021
• Supplement Dates FDA Received: 08/31/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1