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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE Back to Search Results
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.
 
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Brand NameULTRASONIC PROBE
Type of DeviceULTRASONIC 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 Key7887489
MDR Text Key120900416
Report Number2951238-2018-00546
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-S20-17S
Device Catalogue NumberUM-S20-17S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2018
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

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