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

Model Number UM-S20-17S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported device damage cannot be determined at this time.However, the instruction manual warns users to prevent damage to the ultrasonic probe.¿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 patient body due to equipment damage or failure, stop using the equipment immediately and retrieve the part in an appropriate way.¿.

Event Description

Olympus was informed that at the conclusion of an unspecified procedure, the plastic tip and the transducer were noted to be missing from the mini probe.It was reported that the doctor removed the mini probe from the sheath and inserted a brush down the sheath.There was no damage to the mini probe at this time.The brush was removed and the mini probe reinserted.Upon, removing the mini probe, sheath and brush from the sterile field the mini probe damage was noted.The operating room staff were unable to locate the missing components and are believed to be retained inside the patient.The intended procedure was completed with the same device.There was no injury reported and the patient was discharged.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 7887489
• MDR Text Key: 120900416
• Report Number: 2951238-2018-00546
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2018

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
• Device Catalogue Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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